CN116018077A - Sanitary mask with seal forming structure - Google Patents

Abstract

A mask for use at an operating pressure substantially equal to atmospheric pressure includes a body having a three-dimensionally shaped chamber configured to receive a user's mouth and nostrils and operate at an operating pressure. The mask also includes a nasal seal having an uppermost portion that contacts the user's nose along a sagittal plane of the user and around the user's nostrils at least a portion of the user's nose below the user's nasal ridge. on the underside of the department. The mask may include positioning and stabilizing structures to provide a force that holds the seal-forming structure in place against the user. In use, a portion of the positioning and stabilizing structure directly contacts the user's face between the user's lip and the chin prominence.

Description

Hygienic face mask with seal-forming structure

Portions of the disclosure of this patent document contain material that is protected by copyright. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent Office files or records, but otherwise reserves any and all copyright rights.

1 Cross-references to related applications

This application claims the benefit of U.S. Application No. 17/161,846, filed January 29, 2021, which claims the benefit of Australian Provisional Application No. 2020903106, filed August 31, 2020, both of which are incorporated by reference in their entirety This article.

2 background technology

2.1 Technical field

The technology relates to masks or user interfaces, particularly but not exclusively to hygiene masks.

2.2 Related technical description

The human respiratory system facilitates gas exchange. The nose and mouth form the entrance to the human airway.

The airways consist of a series of branching tubes that become narrower, shorter and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to pass from inspired air into venous blood and expel carbon dioxide in the opposite direction. The trachea divides into left and right main bronchi, which eventually divide into terminal bronchioles. The bronchi form the airways and are not involved in gas exchange. Further branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See Respiratory Physiology, 9th Edition, John B. West, Lippincott Williams & Wilkins, 2012.

When inhaling, airborne particles enter a person's airways. These particles can include dirt, bacteria, viruses, or other debris that can harm a person. Similarly, humans exhale particles (eg, liquid droplets, aerosols, etc.). These particles can contain bacteria, viruses or other debris that can harm other people who end up inhaling (or otherwise coming into contact with) the particles.

People may wear face masks to prevent particles from entering their airways and/or to prevent particles from leaving their airways. These masks may be referred to as hygiene masks.

Hygienic masks, such as those worn by medical practitioners (eg, during surgery), can have a number of disadvantages. Known hygiene masks typically have a perimeter extending over the user's nose (eg, sometimes on the nasal ridge and/or bridge), over the cheeks (eg, near or across the cheekbones) and under the chin. Typically, such masks do not conform well to the contours of the user's face around the nose and cheek areas and create one or more spaces between the perimeter of the mask and the surface of the user's face. This may be more noticeable when the user is moving parts of their face (eg, when speaking). When the user exhales, a portion of the exhaled air escapes through this space. This may cause the user to experience dry eye. However, if the user wears glasses (eg, prescription glasses, sunglasses, safety glasses, etc.), the exhaled air directed toward the user's eyes is particularly inconvenient because the exhaled air may cause their glasses to fog up.

Some existing hygiene masks attempt to minimize this problem by providing a malleable metal component on the upper portion of the mask (eg, the portion configured to contact the ridge of the user's nose). The malleable metal part can be deformed by the user to conform to the shape of their nasal ridge. However, such solutions are usually only partially successful, and the spaces or gaps mentioned above will exist to some extent. In other words, although the amount of exhaled air directed toward the user's eyes may be reduced, the user may still experience dry eyes and/or fogging of the glasses.

Users can wear their glasses at different angles on their nose in an attempt to reduce the occurrence of fogging. However, changing the angle and/or position of the glasses may impair the user's vision because the user is no longer looking directly through the glasses.

Similarly, a user may wear glasses in different positions along the ridge of his nose. For example, a user may wear their glasses below the ridge of their nose (eg, closer to the nasal prominence). In some cases, the user may wear glasses on top of the hygiene mask in an attempt to reduce the occurrence of fogging (eg, so that the edge of the mask is farther from the nasal protuberance than where the glasses contact the user's nose). However, this may be uncomfortable for the user and/or may prevent the glasses from sitting snugly on the user's nose.

Hygienic masks that extend over the user's nasal ridge may be subject to additional limitations. Many such masks can be bulky and can reduce the user's field of vision below horizontal. Some potential users may also be limited by the size of traditional face shields and thus avoid their use. In some other cases, a mask with a large footprint on the face results in a large amount of warm air being trapped between the mask and the user's face due to the temperature and humidity of the exhaled breath.

One aspect of the present technology is to provide a mask that overcomes or improves upon at least one problem with prior art masks.

Alternatively, it is an aspect of the present technology to at least provide the public with a useful choice.

3 Contents of the invention

The present technology seeks to provide medical devices for confinement of airborne particles that have one or more improvements in comfort, cost, efficacy, ease of use, and manufacturability.

A first aspect of the present technology relates to an apparatus for limiting the dispersion of airborne particles by limiting inhalation of particles into the airway of a user and by limiting exhalation of particles into the environment.

Another aspect of the present technology relates to a method for limiting the dispersion of airborne particles by limiting inhalation of particles into the airway of a user and by limiting exhalation of particles into the environment.

One form of the present technology includes a mask (eg, a hygiene mask) that forms a seal around the nostrils of a user.

One form of the present technology includes a mask (eg, a hygiene mask) that forms a seal with the front and sides of the perimeter of the wing bases of the user's nose.

Another form of the present technology includes a mask comprising a foam or fabric body and a seal-forming structure of foam.

Another form of the present technology includes a hygienic mask that does not contact the user's nose over the larger wing cartilage and does not extend under the user's chin.

One form of the present technology includes a mask comprising:

a body configured to surround the user's nostrils and the user's mouth; and

a positioning and stabilizing structure to provide a force that holds the body in place on the user's head;

Another form of the present technology includes a face mask (eg, a hygiene mask) that includes a body forming a chamber configured to receive a user's mouth and nostrils at substantially atmospheric pressure.

Another form of the present technology includes a face mask (eg, a hygiene mask) configured to filter inhaled and exhaled air, and to direct the exhaled air away from the user's eyes.

Another form of the present technology includes a mask (eg, a hygiene mask) configured to seal against a user's face and limit airflow leakage from a chamber of the mask.

Another form of the present technology includes a face mask configured to seal against a user's face and prevent airflow between the outer periphery of the mask and the user's skin, the mask including a permeable body configured to allow inhaled and exhaled air through.

Another form of the present technology includes a mask comprising:

subject; and

A seal-forming structure is attached to the body, the seal-forming structure being configured to form a seal around the inlet of the user's airway.

In some forms: a) the body is configured to filter out particulate contaminants in use; b) the mask is configured for use in a hygienic environment; and/or c) the seal-forming structure is configured for use in a user Forms a seal around the mouth of the user and around the nostrils of the user.

Another form of the present technology includes a mask comprising:

main body;

a seal-forming structure coupled to the body, the seal-forming structure being configured to form a seal around the user's mouth and around the user's nostrils; and

A positioning and stabilizing structure to provide a force to hold the seal-forming structure in place on the user's head.

Another form of the present technology includes a mask comprising:

a body defining a chamber; and

A seal-forming structure comprising a cantilever structure extending in use from the main body towards the user's face, the cantilever structure being configured for forming a seal around the lower periphery of the user's nose, the seal-forming structure being further configured for forming a seal around the user's nose The mouth forms a seal,

wherein at least a portion of the body is configured to allow air to pass into and out of the chamber,

the mask further includes a positioning and stabilizing structure to provide a force to maintain said seal-forming structure in place on said user's head;

In the example:

a) the body includes ports through which air can enter and leave the chamber;

b) at least a portion of the body is porous to enable air to enter and exit the chamber;

c) the seal-forming structure includes a portion configured to at least partially seal between the chin and under the lips on the user's face;

d) the cantilever structure seals the alar ridges directly below the user's face;

e) the cantilever structure is lip-sealed to the user's face;

f) the seal-forming structure does not form a seal over the lips directly under the user's nasal septum and under the nostrils;

g) a portion of said cantilever structure extends about 20mm from the main body;

h) the main body is formed from a spacer fabric;

i) the main body forms a cup shape;

j) the body is formed from at least one flat sheet;

k) The body includes at least one pleat.

h) the body is formed from a thermoformed material;

m) the upper central part of the perimeter of the body is equipped with plastically deformable elements;

n) said mask is provided with at least one replaceable filter element;

o) at least one filter element is provided to the interior of the chamber;

p) at least one filter element covers substantially the entire inner surface of the body;

q) the positioning and stabilizing structure comprises two elastic loops, each configured to engage one of the user's ears;

r) the elastic loop is attached to the body around at least a substantial portion of the perimeter of the body;

s) the elastic ring is attached to the body around substantially the entire perimeter of the body; and/or

t) The positioning and stabilizing structure includes at least one strap that is threaded around the back of the user's head.

Another form of this technology includes a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body defining a chamber configured for operation at the operating pressure throughout the breathing cycle of the user and configured for receiving the mouth and nostrils of the user; and

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nose seal which in use extends from the main body towards the user's face in a cantilever structure configured to form a seal around the front and sides of the periphery of the wing bases of the user's nose, and

a mouth seal configured to at least partially form a seal around a user's mouth,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

a positioning and stabilizing structure to provide a force that holds the seal-forming structure in place on the user's head

Wherein at least a portion of the body is configured to allow air to enter and exit the chamber.

In some examples: a) the body includes a port through which air can enter and exit the chamber; b) the body is substantially impermeable and in use air can only pass through the a port enters and exits the chamber; c) at least a portion of the body is permeable such that air can enter and exit the chamber through a surface of the body; and/or d) the mouth is sealed The upper portion is configured to seal between the chin and under the lips on the user's face.

In some examples: a) the cantilever structure seals to the user directly below the alar ridge; b) the cantilever structure seals lipally to the user's face; c) the seal-forming structure is not on the user's forming a seal on the lips directly below the sub-septal point of the user and below the nostrils; and/or d) a portion of the cantilever structure extending about 20mm from the body.

In some examples: a) the body is formed from a spacer stock, foam and/or thermoformable material; b) the body forms a cup shape, wherein the inner surface of the body in use has substantially a positive dome shape; c) the body is formed from a rigid or semi-rigid material; d) the body retains its cup shape regardless of whether the user is wearing a mask; e) the body is formed from a flat sheet of material and includes at least one pleat ; f) attaching said cantilever structure to said body using adhesives, stitching and/or ultrasonic welding; g) the central upper portion of the perimeter of said body is equipped with plastically deformable elements; and/or h) said plasticity The deformation element consists of metal.

In some examples: a) at least one filter element configured to filter air prior to entering and/or exiting the chamber; b) providing the at least one filter element to the chamber the interior surface of the chamber; c) the at least one filter element covers substantially the entire interior surface of the body; d) the interior surface includes at least one fastener; e) the filter element is configured to be removable F) said at least one fastener is formed of a hook and loop material; g) a rigid member coupled to at least a portion of the outer periphery of said filter element; and/or h) The rigid member is elastic and configured to return to the neutral position after the compressive force is removed.

In some examples: a) the positioning and stabilizing structure includes two elastic loops, each configured to engage one of the user's ears; b) the elastic loop is attached to the a body; and/or c) the elastic ring is attached to the body around substantially the entire perimeter of the body.

In some examples: a) the nose seal is configured not to extend into the nostrils of the user; b) the nose seal and the mouth seal are configured to cooperate in use to form a seal against the user's face; c) the nasal seal is constructed from a single piece of material; d) the nasal seal is symmetrical about a central portion configured to contact the user's nose in use near the nasal prominence; e) said cantilever structure includes an at least partially linear front edge; and/or f) said positioning and stabilizing structure is attached to said body in an orientation parallel to said front edge.

In some examples: a) the body includes an outer surface and an inner surface, and an edge between the outer surface and the inner surface; b) the positioning stabilizing structure is attached to the edge; c) adhesive connects the positioning stabilizing structure to the edge; d) the positioning and stabilizing structure includes an upper arm and a lower arm each connected to the edge; and/or e) the upper arm and the lower arm are removed from the nose seal. The central portion is oriented substantially tangentially.

In some examples: a) the nose seal includes a front edge and a rear edge configured to contact the user's face; b) the maximum width between the front edge and the rear edge is configured to contact near the wing base the user; c) the lateral edge of the nose seal comprising a minimum width between the front edge and the rear edge, the lateral edge connecting to the mouth seal; d) the closest maximum The rear edge of the width is arcuate; and/or e) the minimum width between the front and rear edges is substantially equal to the thickness of the mouth seal.

Another form of the present technology includes a sanitary mask configured to filter air inhaled by a user, the sanitary mask comprising:

a body having a three-dimensional shape to form a chamber;

a seal-forming structure configured to seal against the user's face in use; and

A positioning and stabilizing structure coupled to the body, the positioning and stabilizing structure being configured to provide a force to maintain the seal-forming structure in place on the user's head.

In some examples: a) the seal-forming structure is configured to direct air through the body and away from the user's eyes; b) the seal-forming structure forms a single seal around the user's mouth and nostrils; c) the seal forming a structure comprising a nose seal formed from a first sheet of material and a mouth seal formed from a second sheet of material; d) the nose seal is configured not to extend within the nostrils of the user; e) the nose seal comprises a connecting to a front edge of the main body, a rear edge opposite the front edge, and an upper surface extending between the rear edge and the front edge; f) the user's face is configured to contact the rear edge and said upper surface; g) said rear edge comprises a substantially circular shape at a maximum width between said front edge and said rear edge; h) the upper surface proximate said maximum width is configured to be at the wing base i) the nose seal is curved around two axes; j) the width between the front edge and the rear edge is towards the lateral end of the nose seal and the width at the lateral ends is configured to be equal to the thickness of the mouth seal; k) the seal-forming structure is attached to the body near its periphery; and/or l ) The seal-forming structure consists of a fabric material and/or a foam material.

In some examples: a) the body is constructed of a rigid or semi-rigid material and is configured to retain its three-dimensional shape; b) the body has a substantially cup shape and forms a perfect circle relative to the user in use a top shape; c) coupling a deformable element to the inner surface of the body adjacent the outer periphery of the body; d) the deformable element is plastically deformable and configured to maintain its shape; e) the deformable The element is metallic; f) the inner surface of the body is configured to be spaced from the user's mouth in use; g) the inner surface of the body includes a fastener configured to be detachably coupled to the filter h) the body is configured with pleats such that there are substantially no folds along the surface of said body; and/or i) the cavity of the body is maintained substantially at operating pressure in use.

In some examples: a) the material used to construct the body is permeable and configured to allow gas flow through the body into and out of the chamber; b) the material used to construct the body may be cellulose acetate, nitrocellulose ( e.g. collodion), polyamide (e.g. nylon), polycarbonate, polypropylene and/or polytetrafluoroethylene (e.g. polytetrafluoroethylene); c) the body is constructed of fabric and/or foam and/or d) the body is constructed from a spacer fabric.

In some examples: a) the body includes ports through which air can enter and exit the chamber; b) the body is constructed of and/or coated with an impermeable material; c) a filter, which positioned within the port and configured to filter particles from inhaled and/or exhaled air; and/or d) the filter is removable from the port.

In some examples: a) the positioning stabilizing structure is configured to extend around both ears of the user; b) the positioning and stabilizing structure includes a pair of loops each configured to engage one of the user's ears; c) the Each loop of the pair of loops is constructed of an elastic material and is configured to stretch to fit users of different sizes; and/or d) the loops form a continuous perimeter.

In some examples: a) the positioning stabilizing structure includes a pair of upper straps and a pair of lower straps; b) the upper left strap is configured to be connected to an upper right strap in use; c) the upper left strap is configured to be In use connected to the lower left strap; d) The left lower strap is configured to be connected in use to the right lower strap; e) The right lower strap is configured to be connected in use to the right upper strap; f) Using magnets, knots, buttons Buckles, hook and loop material, adhesive, buckles, and/or any other similar fasteners attach these straps together; and/or g) the upper and lower straps are flexible and substantially inextensible .

In some examples: a) a filter element is attached to the body to filter air flowing into and out of the chamber; b) the filter is removably coupled to the body; c) the A filter element is coupled to the inner surface of the body; d) the filter element is configured for engaging a fastener on the inner surface of the body; e) the filter element covers substantially the entire inner surface; f) the The filter element is cleanable and reusable; and/or g) the filter element is replaceable.

Another example of the present technology includes a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensionally shaped chamber configured for operation under an operating pressure and configured for receiving a user's mouth and nostrils, wherein the inner surfaces of the body face each other in use throughout the user's breathing cycle because the user has a substantially positive dome shape; and

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nose seal which, in use, extends from the main body towards the user's face in a cantilevered structure configured to form a seal around the front and sides of the periphery of the wing bases of the user's nose, the The cantilever structure includes

a central portion configured to contact a lower region of the user's nose adjacent to the user's pronata,

a pair of lateral ends configured to contact the user adjacent the nasolabial folds, and

a pair of intermediate portions, each intermediate portion of the pair of intermediate portions is located between the central portion and one of the pair of lateral end portions, each intermediate portion is configured to contact the the user's face near the base of the wings, and

a mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being joined to the pair of lateral ends to form a single, continuous seal,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

positioning and stabilizing structure to provide a force to maintain the seal-forming structure in place on the user's head;

Wherein at least a portion of the body is configured to allow air to enter and exit the chamber.

Another example of the present technology includes a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaping chamber configured for operation at the operating pressure throughout the user's breathing cycle and configured for receiving the user's mouth and nostrils, wherein the interior of the body the surface is spaced in use from the user throughout the user's breathing cycle; and

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nasal seal configured to extend around at least a portion of the user's nostrils on the underside of the user's nose below the user's nasal ridge, and

a mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being connected to the nose seal to form a single, continuous seal,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

positioning and stabilizing structure to provide a force to maintain the seal-forming structure in place on the user's head;

Wherein at least a portion of the body is configured to allow air to enter and exit the three-dimensionally forming chamber.

Another example of the present technology includes a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaping chamber configured for operation at the operating pressure throughout the user's breathing cycle and configured for receiving the user's mouth and nostrils, wherein the interior of the body the surface is spaced in use from the user throughout the user's breathing cycle; and

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure configured and dimensioned to avoid contact with the user's nasal ridge, the seal-forming structure comprising:

a nasal seal having an uppermost portion configured to contact the user's nose along the user's sagittal plane and around at least a portion of the user's nostrils, the at least a portion being located under the user's nose below the user's nasal ridge on the side, and

a mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being connected to the nose seal to form a single, continuous seal,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

positioning and stabilizing structure to provide a force to maintain the seal-forming structure in place on the user's head;

Wherein at least a portion of the body is configured to allow air to enter and exit the three-dimensionally forming chamber.

In some forms: a) the three-dimensionally shaped chamber comprises a cup-shaped chamber; b) the body comprises a two-dimensional stiffening pattern to help maintain the three-dimensionally shaped chamber; c) the two-dimensional stiffening pattern is formed from The center of the body radiates outward; d) the body includes a three-dimensional rigidity to help maintain the three-dimensionally shaped cavity; and/or e) the three-dimensional rigidity and the body are constructed of the same material.

In some forms: a) the body includes ports through which air can enter and exit the three-dimensional forming cavity; b) the body is substantially impermeable and in use air can only enter and exit the three-dimensional forming cavity through the ports chamber; and/or c) wherein at least a portion of the body is permeable such that air can enter and exit the three-dimensionally shaped chamber across the surface of the body.

In some forms: a) the nose seal comprises a cantilevered structure extending in use from the body towards the user's face; b) the cantilevered structure is configured to surround the front of the perimeter of the wing base of the user's nose and side portions to form a seal; c) using a one-piece construction to construct the cantilever structure of the nose seal; d) using adhesives, stitching and/or ultrasonic welding to attach the cantilever structure to the main body; e) the The cantilever structure includes an at least partially linear front edge; f) said positioning and stabilizing structure is attached to said body in an orientation parallel to said front edge; g) a central portion configured to approach (e.g., along the user completely lower than the sagittal plane of the user's nasal process; h) a pair of lateral ends, which are configured to contact the user near the nasolabial fold; i) a pair of middle parts; j) Each intermediate portion of the pair of intermediate portions is located between the central portion and one of the pair of lateral end portions; k) each intermediate portion is configured to contact adjacent to the wing base l) the central portion of the cantilever structure seals to the user's face on the lips; m) the central portion of the cantilever structure is not on the user's lips to form a seal directly under the user's sub-septum and nostrils; n ) the middle portion of the cantilever structure forms the largest width of the cantilever structure; and/or o) the middle portion extends approximately 20 mm from the main body.

In some forms: a) the nose seal includes a front edge and a rear edge configured to contact the user's face; b) each intermediate portion includes a maximum width between the front edge and the rear edge; c) one lateral edge at each lateral end of the nose seal comprises a minimum width between the front edge and the rear edge; d) connecting the lateral edges to said mouth seal; e) said rear edge at arcuate near the middle portion; f) the minimum width between the front and rear edges is substantially equal to the thickness of the mouth seal; g) the bridge is attached to the seal-forming structure; h) the bridge is between each extending between the maximum width of the nose seal; i) the bridge is made of an elastic material and is attached to the seal-forming structure under tension prior to use; j) the bridge is attached to the upper surface of the nose seal, said upper surface is configured to contact a user in use; k) said bridge does not contact said nose seal between the maximum widths of each intermediate portion; l) a cantilever structure of said nose seal is included in the central portion and/or m) said first part and said second part are constructed of the same material and are symmetrical to each other.

In some forms: a) the body is formed from a spacer facestock, foam and/or thermoformable material; b) the body is formed from a rigid or semi-rigid material; c) the body retains its three-dimensional shape for in-use space the inner surface of the body from the user's lips; d) the body is formed from a flat sheet and includes at least one pleat; e) the cantilever is joined using adhesives, stitching, and/or ultrasonic welding. structurally attached to said body; f) the upper central portion of the perimeter of said body is equipped with a plastically deformable element configured to bend and change the shape of the body; and/or g) said plastically deformable element is constructed of metal.

In some forms: a) at least one filter element configured for filtering air prior to entering and/or exiting a chamber; b) providing said at least one filter element to an interior surface of said chamber; c) at least one filter element covers substantially the entire inner surface of the body; d) the inner surface includes at least one fastener, and wherein the filter element is configured to be removably attached to the at least one fastener; e) The at least one fastener is formed of a hook and loop material; f) a rigid member coupled to at least a portion of the outer perimeter of the filter element; g) the rigid member is elastic and configured to return after the compressive force is removed to an intermediate position; h) the inner surface of the body includes a recess, and wherein the filter element is removably positioned within the recess; i) the inner surface of the chamber includes at least one fastener; and/or j) The filter element is configured to be removably attached to at least one fastener.

In some forms: a) the positioning and stabilizing structure includes two elastic loops, each configured to engage one of the user's ears; b) the elastic loop is connected to the the main body; c) the elastic ring is attached to the main body around substantially the entire perimeter of the main body; d) the two elastic rings each form a complete, unbroken perimeter; and/or e) the elastic ring is adjacent to the main body thicker and tapering towards the free end away from the body.

In some forms: a) the nasal seal is configured not to extend into the nostrils of the user; b) the nasal seal is constructed from a single piece of material; c) the nasal seal is symmetrical about a central portion which configured to contact the user's nose in use close to the pronata (e.g., along a sagittal plane substantially below the pronata); d) the cantilever structure includes an at least partially linear front edge; and/or e) The positioning and stabilizing structure is attached to the body in an orientation parallel to the front edge.

In some forms: a) the body includes an outer surface and an edge between the outer surface and the inner surface; b) a positioning and stabilizing structure attached to the edge; c) an adhesive is used to bind the said positioning and stabilizing structure is connected to said edge; d) said positioning and stabilizing structure includes an upper arm and a lower arm respectively connected to said edge; e) said upper arm and said lower arm oriented substantially tangentially; and/or f) the central portion is configured to contact an inferior region of the user's nose proximate (eg, along a substantially inferior sagittal plane) the pronata of the user.

In some forms: a) the nose seal includes a front edge and a back edge configured to contact the user's face; b) the middle section includes a maximum width between the front edge and the back edge; c) The lateral edges at each lateral end of the nose seal include a minimum width between the front edge and the rear edge; d) each lateral edge is connected to the mouth seal; e) the rear The edges are arcuate; and/or f) the minimum width between the front and rear edges is substantially equal to the thickness of the mouth seal.

In some forms: a) the cantilever structure of the nose seal is constructed using a one-piece construction; b) the cantilever structure of the nose seal comprises a first part and a second part joined at a central part; and/or c ) The first part and the second part consist of the same material and are symmetrical to each other.

In some forms: a) ports or channels that are evenly distributed over the surface of the body and that can allow airflow to enter and/or leave the chamber; b) these ports or channels can be positioned to direct airflow away from the user's eyes to avoid irritation or fogging while wearing glasses; c) channels or ports can be positioned towards the bottom of the body to direct air in front, lower and/or lateral directions; d) on at least some of the ports or channels A valve or flap may be included; e) the valve or flap may be a one-way valve and may allow airflow to be drawn into the chamber, but may block airflow exhaled from the chamber; and/or f) the port or channel may include an auxetic material ( or other adaptive material) to adjust (eg, reduce) the diameter of a port or channel during use in order to change the volumetric flow rate through a particular port or channel.

Another form of the present technology includes a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body defining a chamber configured for operation under an operating pressure and configured for receiving a user's mouth and nostrils; and

a deformable member coupled to the upper portion of the body, wherein the deformable member is configured to be positioned, in use, adjacent to the user's nose, below the user's nasal protuberance;

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nasal seal configured to extend on the underside of the user's nose around at least a portion of the user's nostrils, and

a mouth seal configured to at least partially form a seal around a user's mouth,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

positioning and stabilizing structure to provide a force to maintain the seal-forming structure in place on the user's head;

wherein at least a portion of the body is configured to allow air to pass into and out of the chamber; and

Wherein the body and/or the nose seal are selectively movable to conform to the user's face, and the deformable member is plastically deformable and configured to maintain a selected shape.

Another example of the present technology includes a mask for use at an operating pressure equal to atmospheric pressure, the mask comprising:

a body forming a chamber configured for operation at the operating pressure throughout the user's breathing cycle and configured for receiving the user's mouth and nostrils; and

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nose seal which, in use, extends from the main body towards the user's face in a cantilevered structure configured to form a seal around the front and sides of the periphery of the wing bases of the user's nose, the The cantilever structure includes

the front edge, which is attached to the main body,

a rear edge opposite the front edge and configured for contacting the user,

a central portion comprising a first width between the front edge and the rear edge, the central portion configured to contact a lower region of the user's nose proximate to the user's pronata,

a pair of lateral ends configured to contact the user adjacent the nasolabial fold, each lateral end of the pair of lateral ends being included between the front edge and the rear edge a second width of , the second width being less than the first width, and

a pair of intermediate portions, each intermediate portion of the pair of intermediate portions is located between the central portion and one of the pair of lateral end portions, each intermediate portion includes a a third width between the edge and the rear edge, the third width being greater than the first width, each intermediate portion configured to contact a user's face proximate to the wing base, and

a mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being joined to the pair of lateral ends to form a single, continuous seal,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

positioning and stabilizing structure to provide a force to maintain the seal-forming structure in place on the user's head;

Wherein at least a portion of the body is configured to allow air to enter and exit the chamber.

Another form of the present technology includes a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body defining a chamber configured for operation under an operating pressure and configured for receiving a user's mouth and nostrils, the body including at least one fastening member;

a filter removably positioned within the chamber and flippably connected to at least one fastening member;

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nasal seal configured to extend on the underside of the user's nose around at least a portion of the user's nostrils, and

a mouth seal configured to at least partially form a seal around a user's mouth,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

positioning and stabilizing structure to provide a force to maintain the seal-forming structure in place on the user's head;

wherein at least a portion of the body is configured to allow air to pass into and out of the chamber; and

Wherein the filter is configured to substantially cover the inner surface of the body such that inhaled and exhaled air passes through the filter.

Another form of the present technology includes a method for constructing a sanitary mask, the method comprising:

providing a substantially flat sheet;

forming pleats in the sheet of material and folding the sheet of material to form a substantially cup-shaped body, wherein the surface of the folded sheet of material is substantially free of wrinkles;

connecting a nose seal to the cup-shaped body, the nose seal extending from the body in a cantilevered portion, the nose seal being more impermeable than the sheet of material;

connecting the mouth seal to the cup-shaped body and to the nose seal, the combination of the nose seal and the mouth seal forming a complete seal perimeter;

A positioning and stabilizing structure is attached to a surface of the body that is substantially perpendicular to a surface attached to the nasal seal, the positioning and stabilizing structure extending around substantially the entire perimeter of the body.

Another form of the technology includes a method of using a sanitary mask, the method comprising:

providing a hygienic mask comprising a chamber, a seal-forming structure, and a positioning and stabilizing structure;

positioning the hygiene mask in an operative position against a user's face, with the user's nostrils and mouth contained within the chamber;

Secure the positioning and stabilizing structure to the user's head;

sealing the hygiene mask against the user's face using the force provided by the securing; and

Substantially atmospheric pressure is then maintained within the chamber throughout the user's breathing cycle.

Another form of the technology includes a method of using a sanitary mask, the method comprising:

provide hygienic masks with chambers;

Wear a hygienic mask under the user's nasal ridge;

seals the hygiene mask against the user's face and directs inhaled and exhaled air through the body of the mask; and

After sealing, substantially atmospheric pressure is maintained within the chamber throughout the user's breathing cycle.

Another form of the technology includes a method of using a sanitary mask, the method comprising:

donning the sanitary mask comprising a body forming a three-dimensionally shaped chamber;

sealing a seal-forming structure against the user's face to direct inhaled and exhaled air through the body; and

After sealing, substantially atmospheric pressure is maintained within the three-dimensionally shaped chamber throughout the user's breathing cycle.

In some forms: a) the method further comprises positioning the seal-forming structure against the user's face to contact a lower region of the user's nose adjacent to the user's pronata, adjacent to the the central region of the base of the wing, the lateral region adjacent to the nasolabial fold, and the perimeter formed by the region between the user's chin and under the lip; b) the body is formed of a permeable or semi-permeable material; c ) the method further includes receiving the user's nostrils and mouth such that substantially all inhaled and exhaled air passes through the body; and/or d) the method further includes adjusting the width of the body by bending the deformable member, so The deformable member retains its position after removal of the force.

Another form of the present technology is a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaping chamber configured for operation at the operating pressure throughout the user's breathing cycle and configured for receiving the user's mouth and nostrils, wherein the interior of the body the surface is spaced in use from the user throughout the user's breathing cycle; and

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nasal seal configured to extend around at least a portion of the user's nostrils on the underside of the user's nose below the user's nasal ridge, and

a mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being connected to the nose seal to form a single, continuous seal,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

positioning and stabilizing structure to provide a force to maintain the seal-forming structure in place on the user's head;

wherein at least a portion of the body is configured to allow air to enter and exit the three-dimensionally shaped cavity;

wherein the body includes ports through which air can enter and exit the three-dimensional forming chamber, and wherein the body is substantially impermeable and in use air can only enter and exit the three-dimensional forming chamber through the ports. forming chamber; and

wherein the nose seal comprises a cantilever structure extending in use from the body towards the user's face, the cantilever structure being configured to form a seal around the front and sides of the perimeter of the base of the wing of the user's nose .

In some forms: a) the body is constructed from at least one of cellulose acetate, nitrocellulose, polyamide, polycarbonate, polypropylene, and polytetrafluoroethylene; b) the body is at least partially composed of fabric material, and wherein said fabric material is at least partially coated with an impermeable layer; c) said impermeable layer comprises rubber, polyvinyl chloride (PVC), polyurethane (PU), silicone elastomer, fluoropolymer and wax; and/or d) applying the impermeable layer to an inner surface and/or an outer surface of the body, the outer surface being opposite the inner surface.

In some forms: a) the port includes at least one microscopic hole through which air can enter and exit the three-dimensional shaping chamber; b) the port includes at least one visible orifice through which air can enter and exit the three-dimensional shaping chamber; exiting the three-dimensional forming chamber; c) the body is composed of at least a first material and a second material; and/or d) the first material is substantially impermeable, and the second material is more porous than the first material Permeable, wherein the second material forms the port.

In some forms: a) the port is positioned adjacent to a lower region of the body which is adjacent to the mouth seal; b) the port is located along a channel extending between the nose seal and the mouth seal. the central axis of the body is positioned; c) the central axis is configured to be positioned in use parallel to the sagittal plane of the user; d) the port is located close to the side of the body; and/or e) the The sides are adjacent the end of the nose seal and the end of the mouth seal.

In some forms: a) the port is a first port and the body further includes a second port spaced apart from the first port; b) the second port is a one-way valve, the second port is configured to allow air to enter the three-dimensional forming chamber and configured to prevent air from exiting the three-dimensionally shaped chamber; c) the mask is provided with at least one replaceable filter element; d) the filter element is provided to an inner surface of the body; e) the filter element is substantially covering the entire inner surface of the body; and/or f) the filter element is disposed within the port.

In some forms: a) the body is formed from a rigid or semi-rigid material; b) the body retains its three-dimensional shape so as to space the inner surface of the body from the user's lips in use; c) the body the nose seal comprises a cantilevered structure extending in use from the body towards the user's face; d) said cantilevered structure is configured to form a seal around the front and sides of the perimeter of the wing bases of the user's nose; e) a central portion configured to contact the lower region of the user's nose along the user's sagittal plane that is well below the user's nasal protuberance; f) a pair of lateral end portions configured to contact the user near the nasolabial folds ; g) a pair of intermediate portions; h) each intermediate portion of said pair of intermediate portions is located between said central portion and one of said pair of lateral end portions; i) each an intermediate portion configured to contact the user's face near the wing bases; and/or j) the central portion of the cantilevered structure does not form a seal directly on the user's lips at the subseptal point of the user and below the nostrils.

In some forms: a) the positioning and stabilizing structure includes two elastic rings; b) each ring is configured to engage one of the user's ears; c) the positioning and stabilizing structure includes upper arms and lower arm; d) said upper arm and said lower arm are oriented substantially tangentially from a central portion of said nasal seal; and/or e) said central portion is configured to contact said The lower region of the user's nose, the sagittal plane being completely inferior near the user's nasal protuberance.

Another form of the present technology is a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaping chamber configured for operation at the operating pressure throughout the user's breathing cycle and configured for receiving the user's mouth and nostrils, wherein the interior of the body the surface is spaced in use from the user throughout the user's breathing cycle; and

A seal-forming structure configured to form a seal against the user's face in use, the seal-forming structure comprising:

a nasal seal configured to extend around at least a portion of the user's nostrils on the underside of the user's nose below the user's nasal ridge, and

a mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being connected to the nose seal to form a single, continuous seal,

wherein the end of the nose seal is directly connected to the end of the mouth seal; and

a positioning and stabilizing structure to provide a force that maintains the seal-forming structure in place on the user's head; and

at least one filter element configured for filtering air prior to entering and/or exiting said three-dimensionally shaped chamber, and wherein said at least one filter element is provided to an inner surface of said body;

wherein at least a portion of the body is configured to allow air to enter and exit the three-dimensionally shaped cavity;

wherein at least a portion of the body is permeable such that air can enter and exit the chamber through a surface of the body; and

Where a rigid member is coupled to at least a portion of an outer perimeter of the filter element, the rigid member is resilient and configured to return to an intermediate position after the compressive force is removed.

In some forms: a) at least a portion of the body configured to allow air to enter and exit the three-dimensionally shaped chamber comprises a first permeability; b) the filter element comprises a second permeability less than the first permeability; c ) said filter comprises a charge; d) said inner surface of said body comprises at least one fastener; e) filter element is configured to be removably attached to at least one fastener; f) at least one fastener formed from hook and loop material; and/or g) the filter element is substantially flush with said inner surface when attached to said at least one fastener.

In some forms: a) the interior surface of the body includes a recess, and wherein the filter element is removably positionable within the recess; b) the filter element covers substantially the entire interior surface of the body; and/or c) The filter element is constructed of a rigid or semi-rigid material and is configured to act as a rigid member that maintains the three-dimensional shape of the chamber.

In some forms: a) the nose seal comprises a cantilever structure extending in use from the body towards the user's face; b) the cantilever structure is configured to surround the perimeter of the wing base of the user's nose c) the rigid member of the filter element is selectively deformable so as to fit around the cantilever structure; d) the central portion is configured along the sagittal plane of the user contacting the lower region of the user's nose completely below the user's pronata; e) a pair of lateral ends configured to contact the user near the nasolabial folds; f) a pair of intermediate portions; g) the pair of intermediate each intermediate portion of the wings is located between the central portion and one of the pair of lateral end portions; and/or h) each intermediate portion is configured to contact a user near the base of the wing face.

In some forms: a) a central upper portion of the perimeter of the body is provided with a plastically deformable element configured to bend and change the shape of the body; b) said rigid member is more elastic than said plastically deformable element; c ) the positioning and stabilizing structure includes two elastic loops, each configured to engage one of the user's ears; d) the elastic loops are attached to the body around at least a substantial portion of the perimeter of the body; e) the The two elastic rings each form a complete, unbroken perimeter; and/or f) the nasal seal is symmetrical about a central portion configured, in use, along a sagittal plane fully below the nasal procession contact with the user's nose.

Another form of the present technology is a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaping chamber configured for operation at the operating pressure throughout the user's breathing cycle and configured for receiving the user's mouth and nostrils, wherein the interior of the body the surface is spaced in use from the user throughout the user's breathing cycle; and

a nasal seal having an uppermost portion configured and sized to avoid contact with the user's nasal ridge and along a sagittal plane of the user and on the underside of the user's nose Contacting the user's nose below the nasal ridge of the user around at least a portion of the nostril of the user, the nasal seal is constructed of an at least partially impermeable material and is configured to limit, in use, toward the user the airflow of the eyes; and

positioning and stabilizing structure to provide a force to hold the nasal seal in place on the user's head;

Wherein at least a portion of the body is configured to allow air to enter and exit the three-dimensionally forming chamber.

Another form of the present technology is a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaping chamber configured for operation at the operating pressure throughout the user's breathing cycle and configured for receiving the user's mouth and nostrils, wherein the interior of the body the surface is spaced in use from the user throughout the user's breathing cycle; and

a nasal seal having an uppermost portion configured and sized to avoid contact with the user's nasal ridge and along a sagittal plane of the user and on the underside of the user's nose Contacting the user's nose below the nasal ridge of the user around at least a portion of the nostril of the user, the nasal seal is constructed of an at least partially impermeable material and is configured to limit, in use, toward the user the airflow of the eyes; and

a positioning and stabilizing structure that provides a force to hold the nasal seal in place on the user's head, a portion of the positioning and stabilizing structure being configured for under the user's lip in use direct contact between the protuberance and the chin protuberance on the user's face;

Wherein at least a portion of the body is configured to allow air to enter and exit the three-dimensionally forming chamber.

In some forms: a) at least a portion of the body is permeable such that air can enter and exit the three-dimensionally shaped cavity through the surface of the body; c) the cantilever structure is configured to form a seal around the front and sides of the perimeter of the wing base of the user's nose; d) the central portion is configured to be the user's sagittal plane of the user's nasolabial points contacts the lower region of the user's nose; e) a pair of lateral end portions configured to contact the user near the nasolabial fold; f) a pair of medial portions; g ) each intermediate portion of said pair of intermediate portions is between said central portion and a lateral end portion of said pair of lateral end portions; h) each intermediate portion is configured to contact the user's face; i) the central portion of the cantilevered structure does not form a seal on the user's lips directly under the user's nasal septum and under the nostrils; j) the middle portion of the cantilevered structure forms the maximum width of the cantilevered structure; k) the The nose seal includes a front edge and a back edge configured to contact the user's face; l) each intermediate section includes a maximum width between the front edge and the back edge; m) each side of the nose seal a lateral edge at the end comprising a minimum width between said front edge and said rear edge, said lateral edge being connected to said mouth seal; n) a bridge being connected to said nose seal; and/or o) said bridge extends between the maximum width of each intermediate portion.

In some forms: a) the body is formed from spacer stock, foam and/or thermoforming material; b) the upper central portion of the perimeter of the body is equipped with a plastically deformable element configured to bend and change the shape of the body ; c) said plastically deformable element is at least partially enclosed in a sleeve; and/or d) said sleeve is made of a textile material.

In some forms: a) at least one filter element configured to filter air prior to entering and/or exiting a three-dimensional shaping chamber; b) providing said at least one filter element to said three-dimensional shaping chamber inner surface; c) at least one filter element covers substantially the entire inner surface of the body; d) the inner surface of the three-dimensionally shaped cavity includes at least one fastener; e) the filter element is configured to be removably attached to At least one fastener; f) said at least one fastener is formed of a hook and loop material; g) at least one fastener is a plurality of fasteners arranged in a substantially X-shaped configuration; h) said plurality Each of the fasteners extends substantially between the periphery and the center of the main body; i) a rigid member coupled to at least a portion of the periphery of the filter element; and/or j) a rigid member is elastic and configured to return to a neutral position after the compressive force is removed.

In some forms, a) the positioning and stabilizing structure includes two elastic loops; b) each loop is configured to engage one of the user's ears; c) the elastic loop is connected to the the main body; d) the elastic ring is attached to the main body around substantially the entire perimeter of the main body; e) the two elastic rings each form a complete, unbroken perimeter; f) the elastic ring is adjacent to the the main body is thicker and tapers towards a free end away from the main body; g) the elastic ring is configured to at least partially surround the user's mouth and contact the user between the chin and under the lips; h) the elastic ring is formed by at least partially impermeable material construction and configured to restrict airflow into and/or out of the three-dimensional cavity between the positioning and stabilizing structure and the user's face; i) the elastic loop is constructed of a fabric material and is coated with permeable material to restrict airflow; j) each elastic loop is configured to stretch so as to engage one of the user's ears and provide a stretching force configured to pull the body toward the user's face; k) the elastic loop is configured to at least partially surrounds the user's mouth and contacts the user between the chin and under the lips; l) the two elastic rings and the nose seal form a single continuous seal; and/or m) the elastic ring is formed from a single piece of material and runs along the The unbroken lengths are joined together.

In some forms, a) the nasal seal is configured not to extend into the nostrils of the user; b) the nasal seal is constructed from a single piece of material; c) the nasal seal is symmetrical about a central portion configured to be in the Contacts the user's nose in use along a sagittal plane completely below the pronasa point; d) a strap attached to the periphery of the body on the front surface of the body outside the three-dimensional chamber; and/or e) the The straps are configured to add stiffness to the body.

Another form of the present technology is a mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaping chamber configured to operate at the operating pressure throughout a user's breathing cycle and configured to receive the user's mouth and nostrils, wherein the body The inner surface of the is in use spaced from the user throughout the breathing cycle of the user; and

a nasal portion having an uppermost portion configured and sized to avoid contact with the user's nasal ridge and to lie along the user's sagittal plane and on the underside of the user's nose At least a portion of the user's nasal ridge below the user's nostrils contacts the user's nose, the nasal portion being constructed of an at least partially impermeable material and configured to limit, in use, toward the user's eyes airflow; and

A positioning and stabilizing structure to provide a force to hold the nose seal in place on the user's head.

Wherein at least a portion of the body is configured to allow air to enter and exit the three-dimensionally forming chamber.

In some forms, the mask may not include a mouth seal. The positioning and stabilizing structure may contact the user's face in use without providing sealing contact such that the body does not seal against the user's face. Optionally, the positioning and stabilizing structure may contact the user's face in a sealing arrangement such that the nose and positioning and stabilizing structure may at least partially seal the main body against the user's face.

Of course, some of these aspects may form sub-aspects of the present technology. Sub-aspects and/or individual aspects of the aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

Other features of the technology will become apparent from a consideration of the information contained in the following detailed description, abstract, drawings, and claims.

4 Description of drawings

The present technology is illustrated by way of example and not limitation in the various figures of the drawings, in which like reference numbers refer to like elements, including:

4.1 Respiratory Therapy System

Figure 1 shows the human upper airway including the nasal cavity, nasal bones, extranasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. view.

Figure 2 is a front view of a face with several superficial anatomical features identified, including upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal ala, nasolabial folds, and corners of mouth. The directions of up, down, radially inward, and radially outward are also indicated.

Fig. 2-1 is a face front view showing the outer perimeter of the seal contact area along the user's face.

Figure 3 shows a bottom view of the nose with several features identified, including nasolabial folds, lower lip, upper vermilion, nostrils, subseptal point, columella, nasal prominence, nostril major axis, and centrosagittal flat.

Figure 3-1 shows a bottom view of the nose showing the contact area of the seal against the nose.

4.2 Accompanying drawings of embodiments of the present technology

4 is a rear view of a hygiene mask in accordance with one form of the present technology.

4-1 is a rear view of another form of an alternative hygiene mask including a two-dimensional rigidization pattern in accordance with the present technology.

4-2 is a rear view of another form of an alternative hygiene mask including a three-dimensional rigid member in accordance with the present technology.

FIG. 5 is a front view of the mask of FIG. 4 .

5-1 is a front view of another example of a mask including ports for allowing airflow into and out of the chamber.

5-2 is a front view of another example of a mask that includes V-shaped folded material to improve the aesthetics of the mask.

FIG. 6 is a side view of the mask of FIG. 4 with the headgear loops held back.

7 is a perspective view from behind and above the mask of FIG. 4 .

FIG. 8 is a perspective view from behind and below the mask of FIG. 4 .

8-1 is a rear and underside perspective view of another example of a mask showing the dimples on the inner surface of the mask body.

Fig. 9 is a top view of the mask shown in Fig. 4 in a user's use position.

Fig. 9-1 is a top perspective view of the mask of Fig. 4 in the user's use position.

Fig. 10 is a front perspective view of the mask shown in Fig. 4 in a position for use by a user.

10-1 is a front perspective view of the mask of FIG. 4 in the use position on a user wearing glasses.

11A is a top view of the mask of FIG. 4 configured for use by a user with a relatively wide nose.

11B is a top view of the mask of FIG. 4 configured for use by a user with a narrow nose.

Fig. 12 is a side view of the mask shown in Fig. 4 in the user's use position.

12-1 is a side view of the mask of FIG. 4 in the use position on a user wearing glasses.

13 is a rear perspective view of the mask of FIG. 4 with the filter element separated from the main body.

13-1 is a rear perspective view of another example of a mask with a filter element separate from the main body.

13-2 is a rear perspective view of another example of a mask with a filter element separate from the main body.

Figure 14-1 is a front view of the filter element shown in Figure 13 in a compressed position.

Figure 14-2 is a front view of the filter element of Figure 13 returned to the relaxed position.

15 is a rear view of another version of a hygiene mask including a bridge extending through a seal-forming structure.

FIG. 16 is a perspective view from behind and below the hygiene mask of FIG. 15. FIG.

17 is a front view of another form of hygiene mask in accordance with the present technology.

FIG. 18 is a top view of the hygiene mask of FIG. 17. FIG.

19 is a rear perspective view of the hygiene mask of FIG. 17 .

FIG. 20 is a bottom perspective view of the interior of the hygiene mask of FIG. 17. FIG.

21 is a rear view of the hygiene mask of FIG. 17. FIG.

22 is a perspective view of a seal for the hygiene mask of FIG. 17. FIG.

5 specific implementation

Before the present technology is described in further detail, it is to be understood that this technology is not limited to particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing particular examples described herein only and is not intended to be limiting.

The following description is provided in relation to various examples that may share one or more common features and/or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, in any of the examples, any single feature or combination of features can constitute a further example.

In the example shown herein, the mask 3000 is in the form of a hygiene mask, although the mask shown may also be used to filter non-biological particles or contaminants (eg, examples of masks may be used in non-medical settings). In another form, however, the mask 3000 of the present technology may be used to connect a respiratory device to its wearer, for example by providing air flow to an inlet of an airway. Depending on the therapy to be applied, the patient interface may form a seal with, for example, an area of the patient's face, thereby facilitating gas at a pressure sufficiently different from ambient pressure (e.g., between about 6 cmH2O and 20 cmH2O, for example, about 10 cmH2O relative to ambient pressure). Positive pressure of H ₂ O) for delivery to achieve therapy. In an example configured for use as a hygiene mask, the seal is sufficient to seal at normal pressures associated with unassisted inhalation and exhalation. In an example, the mask may be configured to allow a small amount of leakage around the user's mouth, and may only form a seal around the user's nose.

The following description may use terms such as lower or upper and/or front or rear when referring to the position of mask 3000 relative to the user's face. These directions may specifically refer to the orientation of the mask 3000 when the user wearing the mask 3000 is oriented in an upright position (eg, when the user's head is at its highest point, standing up or sitting up). However, the user can move his body (eg, the user can lie on his back) and the mask 3000 will remain positioned (although the orientation term will change).

5.1 Mask body

Referring first to FIGS. 4-8 , some versions of a mask 3000 include a body 3010 . The main body 3010 may also be referred to as a housing. The body 3010 can include an outer perimeter 3012, which can be shaped to substantially correspond to a portion of a user's face. For example, outer perimeter 3012 may have a substantially regular triangular shape (see, eg, FIG. 5 ), and may correspond to a perimeter around a user's mouth. More specifically, the perimeter 3012 of the body 3010 may extend from below the user's lips, radially outward of the user's corner of the mouth, to the user's nasal prominence. The body 3010 may extend upwardly but past the protuberances of the user such that the pronades of the user are not covered by the body 3010 (e.g., when the user is wearing the mask 3000 and standing in an upright position, the body 3010 is completely below the pronata). When the body 3010 is positioned against the user's face in this orientation, the user's mouth and nostrils are positioned radially within the outer perimeter 3012 . In other forms, the outer perimeter 3012 may have a different shape (eg, circular, oval, triangular, rectangular, etc.) and still capture the user's nostrils and mouth within the outer perimeter 3012 . The size and shape of the main body 3010 may contribute to a relatively small area of the mask 3000 so as to minimize obstruction to the user's field of vision.

In some forms, the body 3010 may comprise a three-dimensional shape such that the surface of the body 3010 does not come into contact with the user's face in use. For example, the central portion of the body 3010 may be out of plane relative to the outer perimeter 3012 of the body 3010 . The body 3010 may comprise an arcuate or generally cup-shaped (or dome-shaped) shape such that the outer perimeter 3012 of the body 3010 lies on an imaginary hyperbolic parabolic surface, as shown in FIG. 10 . The inner surface of the body 3010 (eg, the surface facing the user in use) may comprise a substantially positive curvature relative to a user wearing the mask 3000 . For example, the inner surface of the body 3010 may form a true dome shape relative to the user's face in use.

The cup shape of the body 3010 may at least partially form a chamber 3014 into which the user breathes, as best seen in FIG. 7 . The curved shape of the body 3010 separates at least a portion of the body 3010 from the user's face so as to define the volume of the chamber. In use, the user's nose (eg, the user's nostrils) and the user's mouth may extend at least partially into the chamber 3014 . However, the cup-shaped body 3010 limits contact between the user's nostrils and/or mouth and the material of the body 3010 . This may help reduce the feeling of claustrophobia for the user, since the material of the body 3010 does not directly contact and/or block the user's nostrils and/or mouth, and impede the user's breathing. The material of body 3010 may only contact the user's face outside the corners of the user's mouth. In some forms, the material of body 3010 may only contact the user's face at or outside the nasolabial folds on either side of the user's face. In examples where mask 3000 is a hygiene mask, in use, the internal pressure (eg, operating pressure) of chamber 3014 may be substantially equal to atmospheric pressure. In an example (not shown) where the mask is a patient interface for respiratory pressure therapy, the chamber may be an air-filled chamber that may receive pressurized air to help alleviate a user's breathing disorder (eg, sleep apnea).

In some forms, body 3010 may be constructed of a semi-rigid or rigid material. The rigidity of the body 3010 may allow the chamber 3014 to maintain its shape (eg, cup-shaped) whether or not the mask 3000 is in use. The materials used to construct body 3010 may help maintain a constant volume of chamber 3014 while mask 3000 is worn by a user. For example, when a user inhales, the semi-rigid or rigid material is not drawn toward the user's mouth and/or nostrils. This can limit airway obstruction caused by body 3010 and/or can limit discomfort for a user wearing mask 3000 (eg, thereby facilitating increased use of mask 3000). This can limit interruptions when the user is speaking (eg, can reduce muting of the user's voice).

In some forms, a single piece of material (eg, semi-rigid or rigid material) may be used to construct cup-shaped body 3010 . A thermoforming process may be used to maintain the shape of the material in the cup shape (eg, whether or not the mask 3000 is used).

)。例如，该材料通常可以是柔软的和可压缩的，以便为用户提供舒适的配合。两个或多个部件可以超声焊接在一起，以形成主体3010的杯形。In some forms, cup-shaped body 3010 may be constructed using two or more pieces of material (eg, semi-rigid or rigid material). The material may be a spacer material (e.g., approximately 2-3 mm thick spacer material), although any material with similar properties (e.g.,

). For example, the material may generally be soft and compressible to provide a comfortable fit for the user. Two or more components may be ultrasonically welded together to form the cup shape of the body 3010 .

In one form, the two sheets of material are welded together with a curved weld to form the curved cup shape of the body 3010 . Ridges 3034 are formed between the two pieces of material after the weld is completed where it was made. Spine 3034 may increase the stiffness and/or rigidity of body 3010 . This increased stiffness can help maintain the cup shape of the body 3010 (eg, when the mask 3000 is fastened on the user's face).

The radius of curvature of spine 3034 may be inversely proportional to the stiffness of body 3010 . For example, as the radius of curvature increases (eg, forming a flatter curve and approaching a flat surface), the stiffness of the body 3010 decreases. Therefore, it is desirable to form welded spine 3034 with a smaller radius of curvature in order to increase the stiffness of body 3010 .

However, forming the spine 3034 to have a radius of curvature that is too small will result in a body 3010 that does not provide enough room for the user's face. Therefore, the main body 3010 has an ideal aspect ratio range. The two sheets of material can be welded together with a height that is small enough to provide enough stiffness, yet large enough to fit the user's facial features. Similarly, the depth is large enough to fit the user's facial features yet small enough not to unnecessarily obstruct the user's field of view.

In some forms, an additional sheet of material having a V-shaped fold 3035 can be attached to the body 3010 (eg, the exterior surface of the body 3010 and/or the interior surface of the body 3010). V-fold material 3035 may be similar to the material used to construct body 3010 in that the material is permeable (or porous) and does not impede the user's breathing. V-fold material 3035 may be added to cover ridge 3034 and improve the aesthetics of mask 3000.

In some forms (see, eg, FIGS. 6 and 10 ), the material of body 3010 (eg, a single piece of material, or two or more pieces of material) can include at least one pleat 3022 (eg, a pleat on the left side of body 3010 ). one pleat 3022 and one pleat 3022 on the right side). The pleats 3022 may allow the material of the body 3010 to maintain a cupped, bowed shape without wrinkles or other bends in the material. In other words, pleats 3022 can provide a substantially smooth surface (eg, without folds or creases), particularly along outer perimeter 3012 . This can help minimize leakage between the outer perimeter 3012 and the user's face (eg, minimize the flow of inhaled and exhaled air around the mask 3000 rather than through the main body 3010). In some forms, pleats 3022 may not be necessary when body 3010 is thermoformed (eg, when body 3010 is constructed from a single piece of material). In some forms, pleats 3022 may be covered by v-folded material 3035 .

In some forms, at least a portion of body 3010 is configured to allow air to pass into and out of chamber 3014 . In examples where mask 3000 is configured as a patient interface (e.g., for treating a breathing disorder), body 3010 may be equipped with one or multiple ports. Body 3010 may optionally be equipped with one or more vents through which air may enter and/or exit chamber 3014 .

In an example configured for use as a hygiene mask, body 3010 may include a permeable portion through which air may pass. In other words, the user may inhale breathable air from the environment external to chamber 3014 and may exhale air into the external environment. The material of body 3010 allows air to flow between the external environment and chamber 3014 . This helps to reduce the likelihood that the user will continue to inhale previously exhaled air. Body 3010 may be constructed of a permeable material. The body 3010 may be permeable due to material properties (eg, nylon, cotton, or polyester).

The permeability of the material may allow uniform airflow across the surface of the body 3010 . In some forms, body 3010 may be shaped (eg, have a positive dome shape) such that airflow through the permeable material is not directed toward the user's eyes. In other examples, body 3010 may be altered such that the permeable material does not direct airflow into the user's eyes. For example, body 3010 may be coated to alter (eg, reduce) the permeability of certain portions (eg, near the upper portion of body 3010 ). In this way, more airflow (eg, specifically exhaled air) passes through body 3010 away from the user's eyes.

In some forms, the entire body 3010 can be made of an air permeable material (eg, open cell foam, fabric, etc.). For example, the main body 3010 may be constructed of a fabric like spacer stock. Suitable fabrics are described in PCT publication WO2013026091, the entire contents of which are incorporated herein. The permeable material of the body 3010 may also be rigid or semi-rigid in order to maintain the cup shape. As shown in Figure 4-1, the permeable material can also be stiffened (eg, by chemical or mechanical means) to increase the rigidity of the permeable material so that it can maintain a substantially cup-shaped shape. The material may stiffen outward from the center of the mask 3000 (eg, from the spine 3034). For example, body 3010 may be rigid in a direction radiating outward from the center of mask 3000 (eg, in a spider web shape). The two-dimensional stiffening pattern 3038 can help maintain the three-dimensional contour (eg, cup shape) of the mask 3000. However, stiffening pattern 3038 may not prevent a user from manually manipulating body 3010 . The stiffening pattern 3038 will be flexible enough to allow the user to stretch or compress the body 3010 when putting on or taking off the mask 3000, and return the body 3010 to its original shape (ie, cup-shaped) after the user removes the external force. Body 3010 may be selectively stiffened using processes (eg, electrical current, chemical reaction, application of force) described in PCT/SG2020/050792, the entire contents of which are incorporated in their entirety. At least one of the procedures described in PCT/SG2020/050792 may be selectively applied to predetermined locations of the body 3010 in order to stiffen the selected locations. The location can be selected to help maintain the three-dimensional shape (eg, cup shape) of the body 3010 . Alternatively or additionally, stitching may be added to body 3010 in a predetermined pattern in order to selectively stiffen body 3010 .

Alternatively, body 3010 may be permeable due to modifications made during manufacture. For example, body 3010 may be constructed of a material having the properties of an impermeable material. The body 3010 of a mask 3000 (eg, a hygiene mask) can be provided with one or more ports, channels, holes, and/or vents 3030, as shown in Figure 5-1. Ports 3030 (eg, microscopic or visible) can be added to the material to provide selective permeability. Port 3030 may be more permeable than the rest of body 3010 . Body 3010 may also be substantially impermeable and only allow fluid flow between the external environment and chamber 3014 through ports 3030 . Such modified impermeable materials may include, but are not limited to, cellulose acetate, nitrocellulose (e.g., collodion), polyamide (nylon), polycarbonate, polypropylene, and/or polytetrafluoroethylene (teflon). Freon).

In other forms, body 3010 may be composed of a variety of materials. At least one of these materials may be impermeable and configured to restrict airflow. At least one material (other than the impermeable material) may be permeable. At least one permeable material may be selectively placed to function as port 3030 .

In examples with multiple ports 3030 , each port 3030 can be spaced apart (eg, approximately evenly spaced) from adjacent ports 3030 . Port 3030 may be located on body 3010 at a location 1050 that is less likely to cause eye irritation that would cause eyeglass fogging (see, eg, FIGS. 10-1 and 12-1 ). For example, port 3030 may be positioned toward the bottom of body 3010 (eg, along bony ridge 3034 and near portion 3132 so as to be positioned in front of the user's mouth). These ports may be positioned toward the sides of the body 3010 (eg, near the perimeter 3012 of the body 3010) to direct airflow laterally from the user's face. However, the port 3030 may not be positioned toward the top of the body 3010 (eg, near the cantilever portion 3110) to avoid directing air toward the user's eyes. Additionally, ports 3030 may be located throughout body 3010 (eg, top, bottom, middle, and/or sides). The ports 3030 can be configured such that inhaled air can be inhaled through all of the ports 3030 (regardless of location, even if the port 3030 is located near the upper half of the eye), but only one of the ports 3030 is selected to allow the passage of exhaled air, e.g. Port 3030 for eye jets/glasses fogging. For example, port 3030 located near the upper portion of body 3010 (e.g., near cantilever structure 3110) may be configured as a one-way valve and may only allow inhaled air to enter chamber 3014, but may prevent exhaled air from leaving chamber 3014. This can be accomplished with one or more flap valves that open during inhalation and close during exhalation. Or it could be achieved by an auxetic material (e.g., a material that expands when tension is applied) in certain locations (e.g., near the upper portion of the body 3010 of the cantilever structure 3110) that tends to The force generated during this period causes the channel to close. In other examples, at least some of the ports 3030 can be tapered such that the smaller diameter opening is inside the chamber 3014 and the larger diameter is outside the chamber 3014 on the outer surface of the body 3010 . Tapered ports 3030 may allow air to flow more freely in one direction (eg, inhaled air travels into chamber 3014 ) and flow more difficult in the opposite direction (eg, exhaled air out of chamber 3014 ). This is useful in accessing the upper portion of the chamber to limit airflow into the user's eyes.

In an example, mask 3000 is configured such that air passing through ports, holes, or vents 3030 in body 3010 also passes through filter element 3024 (described below). In an example, any and all ports, holes, or vents 3030 provided are located within the perimeter of the seal-forming structure 3100 . The port, hole, or vent 3030 may be near a central region of the body 3010 and substantially aligned with the user's mouth and/or nostrils (e.g., at a common level perpendicular to the sagittal plane) so that inhaled and/or exhaled air is directly Flows through port 3030 and into the user's airway. In other forms, the port, aperture, or vent 3030 may be disposed anywhere along the body 3010 (eg, adjacent the outer perimeter 3012).

In some forms, a deformable object 3028 (eg, a thin metal strip, wire, etc.) may be coupled to body 3010 . Specifically, deformable object 3028 may be coupled to body 3010 near an edge (eg, near outer perimeter 3012). The deformable object 3028 can be deformed by the user to change the shape of the upper portion 3020 of the body 3010 to better fit the shape of an individual user's nose and face (see, eg, FIGS. 11A and 11B ). The deformable object 3028 may be plastically deformable such that it retains its desired shape (ie, does not elastically return to a different position) after being bent or otherwise manipulated. When connected to the body 3010, the deformable object can act as a rigid member and can increase the stiffness of the body 3010.

As shown in FIGS. 20 and 21 , some versions of the mask 3000 can include a sleeve 3029 that can cover a deformable object (eg, deformable object 3028 shown in FIG. 8 ). Sleeve 3029 may be constructed of a comfortable material such as fabric. The material used in sleeve 3029 may also be flexible and may not restrict deformation of deformable object 3028 .

Sleeve 3029 may provide additional support to hold deformable object 3028 in place. Sleeve 3029 can also help limit any inadvertent contact between deformable object 3028 and the user's face.

In an alternative example (not shown), sleeve 3029 may be deformable and may be used with or instead of deformable object 3028 . For example, sleeve 3029 may be rigid (eg, using sutures) or may be formed from a rigid or semi-rigid material that is also comfortable. Sleeve 3029 is elastically deformable to help adjust the shape of mask 3000 .

In some forms, the deformable object 3028 may be positioned proximate to the central upper portion 3016 of the perimeter 3012 of the body 3010 (see, eg, FIG. 8 ). In particular, the user may bend or manipulate deformable object 3028 to conform to the contour of his nose (eg, the lateral curvature of perimeter 1100 ). In this case, the mask 3000 can substantially avoid contacting the nasal ridge of the user. (For example, nose seal 3102 may contact the user's nose completely below the user's nasal ridge). A user with a smaller (e.g., narrower) nose can manipulate the deformable member 3028 to include a smaller radius of curvature, while a user with a larger (e.g., wider) nose can manipulate the deformable member 3028 to include a smaller radius of curvature. Large radius of curvature. Various adjustments may be made by the user (eg, depending on their particular comfort level or position on the user's bridge). Multiple users may also wear a single mask 3000 (eg, the mask 3000 may be reusable and washable), and each user may need to adjust the deformable member 3028 to their respective faces.

In other forms, the deformable object 3028 may extend around different portions of the outer perimeter 3012 of the body 3010 (eg, around the sides and/or around the lower central portion). In other examples, deformable object 3028 may extend around the entire outer perimeter 3012 of body 3010 . A user can adjust different parts of deformable object 3028 to substantially match various parts of their face.

In other forms (not shown), the nasal seal 3102 may contact the nasal ridge of the user such that the pronasa of the user is contained within the chamber 3014 in use. The deformable object 3028 may be used to adjust the shape of the mask 3000 to the shape of the user's nasal ridge (although the deformable object 3028 may not be included).

Some forms of the body 3010 may include a three-dimensional rigid member 3042, as shown in FIG. 4-2. Three-dimensional rigid member 3042 may be constructed of the same material (eg, a permeable material) as body 3010 . In addition to, or instead of, deformable objects 3028 and/or two-dimensional stiffening patterns 3038, three-dimensional rigidizers 3042 may be used. The three-dimensional rigid member 3042 will be flexible enough to allow the user to stretch or compress the body 3010 when putting on or taking off the mask 3000, and return the body 3010 to its original shape (ie, cup shape) after the user removes the external force.

In some forms, three-dimensional rigid members 3042 may be arranged in a pattern similar to two-dimensional rigid member pattern 3038 (eg, in a spider web shape). However, the three-dimensional rigid member 3042 may be spaced apart from the spine 3034 (eg, to avoid interference with the filter element 3024 described below). The three-dimensional rigid members 3042 may extend toward the user's face, although they may be positioned to avoid irritation to the user's face. In other forms, the three-dimensional rigid member 3042 may be connected in other patterns (eg, around at least a portion of the perimeter 3012 of the body 3010). In any mode, the three-dimensional rigid member 3042 helps maintain the three-dimensional shape of the main body 3010 without interfering with user comfort.

As shown in FIG. 17 , some versions of the mask 3000 may include a strap 3044 extending around the perimeter 3012 of the body 3010 . Band 3044 may cover the edges of the material used to form body 3010 (eg, to limit wear and/or increase durability).

The material used to form strap 3044 may include V-shaped folds. For example, the material may have continuous longitudinal folds along its centerline and be "V" shaped. A "V" can be positioned on at least one edge (eg, top and bottom portions of the original edge) of the fabric component (eg, body 3010) to which a V-shaped fold is to be added. Band 3044 may be attached (eg, by stitching, ultrasonic welding, etc.) to body 3010 so as to cover and/or mask the raw edges. In addition to (or instead of) providing the increased durability described above, the strap 3044 can be visually pleasing.

In some forms, strap 3044 may be constructed of a flexible material. For example, strap 3044 may be constructed of a material similar to body 3010, such as fabric. Band 3044 may not be substantially impermeable (eg, coated with an impermeable material) because it may cover a portion of body 3010 that may already be at least partially impermeable (although band 3044 may still be impermeable).

In some forms, strap 3044 may be constructed of a rigid or semi-rigid material, and may also add some stiffness, stiffness, and/or support to perimeter 3012 of body 3010 . This can help body 3010 maintain a desired shape (eg, cup shape).

In one form, the band 3044 can be constructed at least in part from a deformable object (eg, similar to an alternate version of the deformable object 3028 or the sleeve 3029 ). Deformable objects can be rigid or semi-rigid. This may allow a user to bend or manipulate strap 3044 in order to adjust the shape of perimeter 3012 . The strap 3044 can maintain a desired shape while being bent or manipulated.

In some forms, the material of body 3010 at perimeter 3012 may be hot stamped and/or ultrasonically welded to provide rigidity to the perimeter and/or increase the durability of body 3010 . Hot stamped and/or ultrasonically welded body 3010 may not include strap 3044, although some examples may include both.

In some examples, the body 3010 is made of fabric, wherein the outer surface (ie, the surface exposed to the external environment) has some degree of water resistance. This can be achieved through the material properties of the fabric or by applying a coating on the outer surface. In some forms, the coating may not substantially affect the permeability of the body 3010 . In some forms, the coating can render the body 3010 impermeable, and air can enter and/or exit the chamber 3014 through ports, holes, or vents 3030 . In some examples, the coating may also be applied to the interior surface 3032 of the body 3010 (ie, the surface within the chamber 3014). Water repellent coatings can help limit the saturation of fabric materials with exhaled water vapor. The coating can be rubber, polyvinyl chloride (PVC), polyurethane (PU), silicone elastomer, fluoropolymer and/or wax.

Alternatively, a material having waterproof properties may be detachably attached to the inside of the main body 3010 . In other examples, the material may be a media capable of filtering particles of certain sizes (eg, filter media 3024 described below). Users can optionally choose whether to use removable materials.

In some forms, the inner surface 3032 of the body 3010 within the chamber 3014 can include at least one fastener 3026 for coupling the removable material to the mask 3000 . In some forms, body 3010 can include a pair of fasteners 3026, one on a side of body 3010 (eg, left and right). In some forms, the body 3010 can include a plurality of fasteners 3026 (eg, three, four, five, etc.) spaced around the body 3010 . Fasteners 3026 may be arranged symmetrically about body 3010, although fasteners 3026 may also be arranged in an asymmetrical pattern. Fasteners 3026 may be hook and loop material, magnets, mechanical snaps, or any other similar fastening elements that allow for a detachable connection.

As shown in FIG. 8 , inner surface 3032 of body 3010 may include a pair of fasteners 3026 . Fasteners 3026 may be positioned on the sides of body 3010 as previously described. For example, fastener 3026 may be adjacent to nose seal 3102 (described below). In some forms, the fastener 3026 may not extend all the way to the middle of the body 3010 . In other words, only discrete portions of the sides of inner surface 3032 include fasteners 3026 . This helps provide comfort to the user wearing the mask 3000 without the filter element 3024 (eg, to minimize potential contact between the rough hook and loop material and the user's skin).

As shown in FIGS. 20 and 21 , the inner surface 3032 of the body 3010 may include four fasteners 3026 (eg, two pairs of fasteners 3026 ). The fasteners 3026 can be arranged in a triangular or diamond shape (although the fasteners 3026 can be arranged in other shapes, like an X shape, an at least partially circular shape (e.g., a circle), a rectangular shape, etc.), and can be obtained from Edges of inner surface 3032 extend toward the center of inner surface 3032 (eg, diagonally). The fasteners 3026 in each pair may have substantially the same length and extend at similar angles such that the fasteners form a symmetrical pattern.

In other examples, inner surface 3032 of body 3010 may include any number of fasteners 3026 . For example, inner surface 3032 may include one or more fasteners, such as two, three, or four fasteners, or more than four fasteners (such as five, six, seven, eight, etc. )3026. These fasteners 3026 may have different shapes than the fasteners 3026 shown in FIGS. 8 and 20 . Instead of strips (as described above), at least some of the fasteners 3026 may be circular, oval, triangular, square, or any other shape. Fasteners 3026 may be arranged in any pattern sufficient to attach to filter element 3024 .

In some examples, one pair of fasteners 3026 may be longer than the other pair of fasteners 3026 . In other examples, all fasteners 3026 may be positioned at the same angle and/or have the same length.

In the form shown, the fastener 3026 of FIGS. 8 , 20 and 21 includes hook material and is configured to attach to loop material (eg, on the filter 3024 ). In some forms, the hook material of the fastener 3026 can harden along the length and can help maintain the shape of the body 3010 .

Some forms of the inner surface 3032 of the body 3010 may include dimples 3046 as shown in FIG. 8-1 . For example, recess 3046 may be joined (by stitching, ultrasonic welding, etc.) to inner surface 3032 around a portion of the perimeter of recess 3046 . At least one fastener 3026 can be coupled to inner surface 3032 within and/or adjacent to recess 3046 (see, eg, FIG. 13-2 ). The recess 3046 may substantially follow the curvature of the body 3010 to create a substantially small opening to the recess 3046 and limit reduced user comfort.

5.1.1 Spacer Fabric

A spacer fabric may be defined as a fabric having an upper grounding structure or layer, a lower grounding structure or layer, and floats or wefts woven between the upper and lower grounding structures to form a matrix-like fabric.

The upper grounding structure and the lower grounding structure may be formed from a fabric. The upper ground structure may have different properties than the lower ground structure, for example they may have different stretch, stiffness, flexibility, feel, or other properties. The upper and lower ground structures may be substantially parallel to each other. The spacer fabric may be formed by jersey knitting. At least one side (ie, the upper or lower ground contact structure) may be formed from a fabric having yarns of, for example, about 30-100 denier, 20-300 denier, or 50-200 denier for a comfortable hand. This can reduce irritation of the main body 3010 when it comes into contact with the user's skin.

5.2 Seal forming structure

As shown in Figures 2-1 and 7 through 8-1, some forms of the present technology may include a seal-forming structure 3100 that provides a targeted seal-forming area, and may additionally provide a cushioning function. A target seal-forming area is an area on seal-forming structure 3100 where a seal is likely to occur and form a sufficient seal. The area where the seal actually occurs - the actual sealing surface - may vary over a given lifetime, from day to day, and from user to user, depending on a range of factors including, but not limited to, where the mask is placed on the face, positioning and stabilizing structures tension and/or the shape of the user's face. The target seal forming area may be large enough to maintain substantially the same seal with a different actual sealing surface. In other words, because the target seal-forming area is large enough to include many actual sealing surfaces, the same user placing the seal-forming structure 3100 on a slightly different location on its surface will experience substantially the same seal.

In the example shown in FIGS. 7 to 8-1 , seal-forming structure 3100 may include lower nose seal 3102 and/or mouth seal 3104 . Lower nose seal 3102 may extend substantially in a different plane 3106 than plane 3108 of mouth seal 3104 . The two seals 3102 , 3104 can work together to form a seal between the user's face and the mask 3000 around substantially the entire outer perimeter 3012 of the seal-forming structure 3100 . For example, the two seals 3102, 3104 together form a single seal to the user's face, which may surround the user's nostrils and the user's mouth.

As shown in FIG. 7 , prior to use in some forms, plane 3106 may be relative to central axis 3107 (eg, an axis that is collinear or parallel with spine 3034 in use, and/or parallel or coplanar with the sagittal plane) tilt. Force from the user's nose may cause the angle between plane 3106 and central axis 3107 to increase further. However, the material of the nose seal 3102 may have sufficient stiffness to limit significant increases in angle. In some forms, the angle 3109 between the plane 3106 and the central axis 3107 may be between about 100° and about 170° prior to use. In some forms, the angle 3109 between the plane 3106 and the central axis 3107 may be between about 110° and about 140° prior to use. In some forms, the angle 3109 between the plane 3106 and the central axis 3107 may be between about 115° and about 125° prior to use. In some forms, the angle 3109 between the plane 3106 and the central axis 3107 may be about 120° prior to use.

As shown in Figure 7, the angle between plane 3106 and central axis 3107 can be designed to accommodate users with large angles between their columella and upper lip. In some forms, the angle between the columella and the upper lip can substantially match the angle between the plane 3106 and the central axis 3107 . Substantially matching the angle between plane 3106 and central axis 3107 to the angle on the user's face promotes an effective seal in users with large angles between the columella and the lip. Users with a smaller angle between their columella and lip can bend the nose seal 3102 into contact between their nose and the mask 3000 and change the angle between the plane 3106 and the central axis 3107 to substantially correspond to its face (eg, and create an adequate seal).

5.2.1 Lower nose seal

As shown in FIGS. 4 and 7 , the nose seal portion 3102 of the seal-forming structure 3100 is configured to surround the perimeter 1100 of the user's nose (e.g., as shown in FIG. 3 ) and/or around the sides of a portion of the user's nose proximate to the perimeter 1100 Form a seal. Perimeter 1100 may extend around at least a portion of the user's nostrils (eg, around a nose rim radius) on the underside (eg, lower portion) of the user's nose. The underside of the nose may be lower than the pronata of the user and the ridge of the user's nose (eg, adjacent to or near the columella). In particular, perimeter 1100 may extend from the user's wing adjacent to the base of their lips, and along the alar of their nose back to the base of the wing. The central portion of the seal-forming structure 3100 may be positioned along the user's sagittal plane in use, and may be positioned well below the user's pronata (eg, when the user is in an upright position). The perimeter 1100 may extend radially outward of the perimeter of both nostrils (eg, and not intersect with and/or extend into either nostril). Perimeter 1100 may also extend to the user's nasopoints. For example, the pronata of a user's nose may be on the outer edge of perimeter 1100 . In general, perimeter 1100 may form a generally C-shape or a generally U-shape. In other words, the perimeter 1100 may not intersect the user's sagittal plane along the user's lips (although some versions may include a completely closed perimeter).

As shown in FIG. 4 , some forms of the nose seal 3102 include a cantilever structure 3110 that extends from the body 3010 toward the center of the mask 3000 (eg, radially inward from the outer perimeter 3012 ). The cantilever structure 3110 may be fixed near the outer edge of the main body 3010 . The free end of the cantilever structure 3110 can be positioned towards the center of the mask 3000 . The free end of the cantilever structure 3110 is able to move into and out of the chamber 3014 depending on the direction of the applied force.

As shown in FIG. 4 , some versions of the mask 3000 may include two cantilevered portions 3110 . For example, the mask 3000 may include cantilevered portions on either side of the mask 3000 (ie, the right and left sides). Each cantilever portion 3110 can be symmetrical about the central axis 3107 of the mask 3000 . The cantilevered portions 3110 can be joined together near the central axis 3107 of the mask 3000 (eg, near the user's nasal prominence at a location intended to contact the user's nose). For example, a central portion of cantilever portion 3110 (eg, intersecting central axis 3107 ) may contact the user's nose along the user's sagittal plane. The cantilevered portion 3110 can contact the user's nose along the perimeter 1100 such that along the sagittal plane, the cantilevered portion 3110 avoids contact with the user's nasopoint (e.g., when the user is in an upright position, the cantilevered portion 3110 is close to the user's nasopoint). extending but lower than the user's nasopoint). The exposed surfaces of the seams between the cantilever portions 3110 may be substantially smooth so as to reduce irritation to the user's skin. Any bumps or protrusions may be provided on opposing surfaces of the cantilever portion 3110 within the chamber 3014 to avoid contact with the user's skin.

Certain forms of cantilever portion 3110 may avoid obstruction of fastener 3026 as shown in FIG. 8 . In other words, cantilever portion 3110 may not extend over fastener 3026 such that fastener 3026 is visible. This may assist the user in aligning filter element 3024 (described below) with fastener 3026 .

As shown in FIG. 7 , cantilever portion 3110 may include a front edge 3120 and a rear edge 3126 . Front edge 3120 can be substantially linear and can extend the entire length of cantilevered portion 3110 . The rear edge 3126 of the cantilever portion 3110 can be at least partially arcuate. For example, cantilevered portion 3110 may curve from central portion 3122 to maximum width 3140 . In particular, the rear edge 3126 may have a positive curvature relative to the user's nose in use. In some forms, the radius of curvature at maximum width 3140 may be between about 10 mm and about 50 mm. In some forms, the radius of curvature at maximum width 3140 may be between about 20 mm and about 40 mm. In some forms, the radius of curvature at maximum width 3140 may be between about 25 mm and about 35 mm. In some forms, the radius of curvature at maximum width 3140 may be about 30 mm.

Maximum width 3140 may be the length of a chord extending from rear edge 3126 and perpendicular to front edge 3120 . In some forms, the measured maximum width 3140 is less than twice the radius of curvature (eg, portion diameter) because the leading edge 3120 is substantially linear. For example, the measured maximum width 3140 may be between about 25% and about 95% of twice the radius of curvature. For example, the measured maximum width 3140 may be between about 40% and about 80% of twice the radius of curvature. For example, the measured maximum width 3140 may be between about 50% and about 70% of twice the radius of curvature. For example, the measured maximum width 3140 may be approximately 66% of twice the radius of curvature.

In some forms, the maximum width 3140 may be measured between about 1 mm and about 50 mm. In some forms, the maximum width 3140 may be measured between about 10 mm and about 40 mm. In some forms, the maximum width 3140 may be measured between about 15mm and about 30mm. In some forms, the measured maximum width 3140 may be approximately 20 mm.

Some forms of cantilevered portion 3110 may be an intermediate portion between central portion 3122 and lateral portion 3124 as shown in FIGS. 4 through 4-2. However, cantilever portion 3110 may be asymmetric on either side of maximum width 3140 between central portion 3122 and lateral portion 3124 . For example, maximum width 3140 may not be cantilevered portion 3110 may be off-center. In some forms, the maximum width 3140 may be closer to the lateral portions 3124, which may create more space between the two maximum widths 3140 (e.g., on either side of the central portion 3122), which may provide greater flexibility for the user. The nose offers more space. In other forms, maximum width 3140 may be evenly spaced between central portion 3122 and lateral portions 3124 , or maximum width 3140 may be disposed closer to central portion 3124 .

In some forms, the shape of the cantilever portion 3110 may be non-uniform on either side of the maximum width 3140 . For example, cantilever portion 3110 can be substantially linear between maximum width 3140 and lateral portion 3124 (eg, length is tangent to a radius at maximum width 3140 ). This distance may be inclined relative to front edge 3120 . In some forms, the length may include a curvature proximate to lateral portion 3124 . This can provide a substantially smooth transition between the front and rear edges 3120, 3126 so as to limit irritation to the user's skin. In some forms, the radius of curvature at maximum width 3140 may be between about 10 mm and about 50 mm. In some forms, the radius of curvature at maximum width 3140 may be between about 20 mm and about 40 mm. In some forms, the radius of curvature at maximum width 3140 may be between about 25 mm and about 35 mm. In some forms, the radius of curvature at maximum width 3140 may be about 30 mm.

In some forms (see, eg, FIGS. 4 and 7 ), the width between front edge 3120 and rear edge 3126 at lateral edge 3124 may be substantially negligible. In other words, the curvature near lateral edge 3124 may merge rear edge 3126 into front edge 3120 such that there is substantially no thickness between edges 3120 , 3126 .

With continued reference to FIGS. 4 and 7 , some forms of the cantilever portion 3110 may be symmetrical about the central portion 3122 regardless of whether the cantilever portion 3110 is constructed from a single piece of material or from separate materials. In a one-piece construction, the central portion 3122 is not an edge, but merely marks the axis of symmetry. In a multi-piece construction, the central portion 3122 is the edge on either cantilevered portion 3110 before the cantilevered portions 3110 are joined.

In some forms, the length between the central portion 3122 and the lateral edges may be between about 50 mm and about 150 mm. In some forms, the length between the central portion 3122 and the lateral edges may be between about 75 mm and about 125 mm. In some forms, the length between the central portion 3122 and the lateral edges may be between about 80 mm and about 100 mm. In some forms, the length between the central portion 3122 and the lateral edges may be about 89 mm. In some forms, the length can be adjusted on different sized masks 3000 to fit different sized faces. For example, some forms may be no more than about 15 mm (eg, about 74 mm) in length. As described below, this reduced length can still provide sufficient face contact to form a hygienic mask quality seal.

In some forms, the cantilever portion 3110 is attached to the main body 3010 with an adhesive (eg, glue). For example, adhesive may be applied along front edge 3120 and/or inner surface 3032 proximate outer perimeter 3012 . The adhesive can form a substantially airtight interface between the cantilever portion 3110 and the body 3010 so as to limit leakage. Adhesives may also be used to increase the rigidity of mask 3000 (eg, adhesives may serve as rigidizers). In other examples, the cantilever portion 3110 and the main body 3010 may be connected to each other using different methods (eg, ultrasonic welding, mechanical coupling, magnets, etc.). These other attachment methods can also be used as rigid members of the mask 3000. In other examples, the cantilever portion 3110 and the main body 3010 may be constructed from the same piece of material in a single piece and/or integrally connected. Once the cantilever portion 3110 is attached to the body 3010, in use, the rear edge 3126 may be positioned closer to the user's face than the front edge 3120 (eg, positioned further back).

As shown in FIGS. 4 and 7 , the front edge 3120 of the cantilever structure 3110 is curved out of plane to match the perimeter 3012 of the body 3010 . In other words, the compliant nature of the material used in cantilever structure 3110 allows front edge 3120 to bend along outer perimeter 3012 and match the shape of body 3010 . The cantilevered portion 3110 may bend about an axis that in use is directed toward the user's face (eg, about an axis parallel to or coplanar with the sagittal plane, or an axis inclined relative to the sagittal plane). In some forms, the central portion 3122 of the front edge 3120 of the cantilever structure 3110 is higher than the lateral portions 3124 of the front edge 3120 of the cantilever structure 3110 due to the curvature. In some forms, the central portion 3122 may be more forward than the lateral portions 3124 as a result of the curvature (eg, because the user's nasal prominence may be the most forward facial feature). Because the cantilever structure 3110 is curved, portions of the rear edge 3126 (ie, the free end) can be configured to move into the chamber 3014 in different directions. For example, FIG. 7 shows that the portion of the posterior edge 3126 near the central portion 3122 is oriented in a substantially horizontal direction (e.g., in a substantially lateral direction intersecting the user's sagittal plane), and that the proximal portion of the posterior edge 3126 Portions of the lateral portions 3124 are oriented in a substantially vertical direction (eg, in use substantially downward). In some forms, cantilevered portion 3110 may curve around maximum width 3140 on either side of the central portion. In other words, the arcuate portion adjacent maximum width 3140 may be a transition between a substantially horizontal portion and a substantially vertical portion.

The rear edge 3126 proximate the center portion 3122 can move in the downward direction into the chamber 3014 , while the rear edge 3126 proximate the side portions 3124 can move in the anterior direction into the chamber 3014 . The curvature of the cantilever structure 3110 can stiffen the cantilever structure 3110 so that it can resist bending in the downward direction better than if the entire cantilever structure 3110 were substantially planar when connected to the body 3010 (e.g., when the underside or underside of the user's nose is deflected downward).

The cantilever structure 3110 is configured to engage the lower perimeter 1100 of the user's nose without blocking the user's nostrils, or at least without significantly or completely blocking the nostrils (see, eg, FIG. 3-1 ). In other words, the portion of the cantilever portion 3110 between the two largest widths 3140 may include a curvature (eg, C-shape or U-shape) as a result of the connection to the body 3010 . The shape may substantially conform to the shape of the perimeter 1100 of the user's nose. In particular, the rear edge 3126 of the cantilever structure 3110 can be shaped to substantially conform to the shape of the outer edge of the lower surface of a typical user's nose (eg, along the user's flange). Additionally, the maximum width 3140 may be configured to contact the user's face near the base of the wing. The curvature at maximum width 3140 can provide a comfortable interface against the user's skin. The maximum width 3140 may extend along the sealing perimeter 1105 past the corner of the user's nose near the base of the wing. In some forms, the cantilever structure 3110 near the maximum width 3140 may wedge in the corner area of the user's nose near the base of the wing. The wedge material can help provide an effective seal and reduce the possibility of leaks in this area. As shown in Figure 3-1, some forms of cantilever structure 3110 may not extend around the entire perimeter 1100, and may diverge from the user's nose near corner areas so as to bridge the space between perimeter 1100 and the user's cheek.

As shown in FIG. 2-1, the nasal seal 3102 may contact the user's face between the alar and nasolabial folds so as to bridge the corners of the user's nose. The specific cantilever shape and maximum width portion 3140 can help wedging corner areas and creating an effective seal. The seal may then contact the user's face outside the corners of the mouth and around the mouth and along the total seal perimeter 1105, as described.

As noted above, in some examples, by bending deformable object 3028 in body 3010, rear edge 3126 can be changed in shape (eg, made narrower or wider). For example, FIG. 11A shows the deformable element 3028 configured for a wider and/or shorter nose, and FIG. 11B shows the deformable element configured for a narrower and/or longer nose. The deformable element 3028 allows the user to adjust the shape of the nose seal 3102 to better conform to their face.

As shown in FIG. 9 , the cantilever structure 3110 may be configured to seal both sides of the lower perimeter 1100 of the user's nose from a point immediately below the tip of the nose to the point where the nose meets the face (directly below the wing tops). The cantilever structure 3110 contacts and/or seals against the user's nose slightly below the user's pronata so that in use the pronata are not located within the chamber. However, the cantilever structure 3110 may not extend beyond the pronax of the user (eg, may not contact the spine of the user's nose). In some forms, the cantilever structure 3110 may not extend over the tip of the user's nose. However, other forms (not shown) may include a cantilever structure 3110 that contacts the user's nasal ridge and/or extends over the user's nasal prominence.

In use, the user's nose may press down (i.e., in a downward direction) on the upper surface 3128 of the cantilever structure 3110, adjacent to the rear edge 3126 of the cantilever structure 3110, causing the cantilever structure 3110 to bend downward (i.e., in a downward direction). up). The cantilever structure 3110 can exert an opposing force on the underside or portion of the user's nose, thereby sealing the lower perimeter of the user's nose. This can provide some resistance to the cantilever structure 3110 so that the user's nose does not sink completely into the chamber 3014 and create a good seal between the nose seal 3102 and the user's face.

As shown in FIGS. 15 and 16 , some forms of mask 3000 may include a bridge 3152 to provide additional support for the user's nose and to provide additional resistance so that the user's nose does not sink completely into chamber 3014, and A good seal is established between the nose seal 3102 and the user's face.

As shown in FIG. 15 , bridge member 3152 extends through cantilever structure 3110 . Bridge 3152 may be connected to a portion of cantilever structure 3110 . For example, bridge 3152 may cover cantilever structure 3110 and may be bonded (eg, attached by adhesive) to cantilever structure 3110 . The bridge 3152 can be substantially thinner (eg, compared to the thickness of the cantilever portion 3110). The substantially small thickness of bridge 3152 can maintain substantially smooth and/or flush upper surface 3128 of cantilever portion 3110 . For example, bridges 3152 may not protrude significantly from upper surface 3128 to limit creation of ridges or corners that may cause irritation to a user. This can help provide a comfortable surface for the user (eg, upper surface 3128).

In some forms, bridge 3152 may extend between locations proximate lateral portion 3124 . Bridge 3152 may also intersect rear edge 3126 proximate maximum width 3140 on either side of cantilever structure 3110 . This can create a substantially curved path that bridge 3152 follows. As shown in FIG. 16 , the central portion of bridge 3152 may extend between rear edge 3126 (or rear edges 3126 ) between maximum width 3140 and may be unsupported (i.e., may not cover cantilevered portion 3110 ). In some forms, the bridge 3152 can be attached to the unsupported region in a substantially tensioned orientation.

In some forms, the bridge 3152 is formed from a piece of material that is about 1 mm to about 15 mm wide (eg, measured in the front-to-back direction). In some forms, bridge 3152 is formed from a sheet of material that is about 5 mm to about 10 mm wide. In some forms, bridge 3152 is formed from a single piece of material that is about 7 mm wide.

In some forms, bridge 3152 is formed from a piece of material that is about 10 mm long and about 50 mm long (eg, measured between rear edge 3126 (or maximum width 3140 of rear edge 3126 )). In some forms, the bridge 3152 is formed from a piece of material that is about 20 mm long and about 40 mm long. In some forms, bridge 3152 is formed from a single piece of material that is approximately 35 mm in length.

By adding bridges 3152, mask 3000 can contact the entire perimeter around the user's nose. For example, cantilever structure 3110 contacts perimeter 1100, as described in previous examples. The inclusion of bridges 3152 forms the complete perimeter to receive the user's nostrils. In other words, the bridge 3152 contacts the user's face between the wing bases and across the lips. Bridge 3152 may contact the user's nasal septum, and the user's nostrils may extend into and partially through the space formed by cantilever structure 3110 and bridge 3152 .

The bridge 3152 is configured to deform when in contact with the user's upper lip. Bridge 3152 may be constructed of a flexible material and be unsupported, allowing it to bend when force is applied. In some forms, bridge 3152 may be constructed of a resilient material. The elastic material can help the bridge 3152 to stretch, which can help improve user comfort. For example, the elasticity in the bridge 3152 can provide and limit the stiffness of the material in contact near the supralabial and/or nasal prominence (eg, which can be a sensitive area). After each use, the bridge 3152 is elastically deformable and returns to its original tensioned position.

In some forms, the position of the cantilever structure 3110 can be moved by bending the deformable member 3028 . As the deformable member 3028 is moved to a wider orientation, the elastic material of the bridge 3152 is stretched and held in a tensioned position. Moving the deformable member 3028 does not move the bridge 3152 into the plastically deformed region, which allows the bridge 3152 to stretch further upon contact with the user and return to its original tension when the deformable member 3028 is moved into the narrower orientation Location. When the deformable members are moved to the narrower orientation, the elastic material remains in the taut position so that users with narrower noses can retain the benefits of the elastically deformable bridges 3152 .

In some forms, bridges 3152 can assist a user in properly orienting mask 3000 on their face. For example, the bridge 3152 can constrain the user from positioning the cantilever structure 3110 above the nasal prominence and in contact with the nasal ridge. The material of bridge 3152 and opening 3156 formed by cantilever structure 3110 and bridge 3152 encourages the user to properly orient their nose within mask 3000 . The size of the opening 3156 generally corresponds to the size of the user's nose, thereby encouraging the user to properly position their nose within the mask 3000 . As noted above, the deformable object 3028 can be adjusted to change the size of the opening 3156 and accommodate different sized noses, while still limiting incorrect positioning of the user's nose.

In some forms, bridge 3152 may limit the user's nose from fully extending into chamber 3014 . Bridge 3152 may provide a counter force due to contact with the user's nose. In other words, the tension in bridge 3152 limits the length extension of bridge 3152 . Accordingly, the bridge 3152 can assist in properly orienting the user's nose in an up-down direction. Tension in bridge 3152 may prevent the user's nose from extending too far into chamber 3014 (eg, where the bridge of the nose is at least partially within chamber 3014 ). The nose can then contact the cantilever portion at the desired location and form a seal.

The cantilever structure 3110 may be constructed of a foam, such as a closed cell foam (eg, Belmont foam). The foam can be substantially airtight. In other words, the foam may have a relatively low permeability compared to the material of the body 3010 such that air passes through the body 3010 but not the cantilever structure 3110 . Alternatively, the foam can be completely impermeable. For example, the foam can be thicker than the material of the body 3010 (eg, textile), which can help reduce permeability. In some forms, the foam may be between about 1 mm thick and about 20 mm thick. In some forms, the foam may be between about 2mm thick and about 15mm thick. In some forms, the foam may be between about 4mm thick and about 10mm thick. In some forms, the foam may be between about 6mm thick and about 10mm thick. In some forms, the foam may be about 8mm thick.

In an example, cantilever structure 3110 can be a semi-permeable foam or can include holes (eg, similar to ports 3030 ), which can be spaced substantially evenly. Any apertures may be positioned to direct airflow away from the user's face in order to reduce eye irritation or fogging caused by glasses 1050 when worn (see, eg, FIGS. 10-1 and 12-1 ). For example, holes in the cantilever structure 3110 may be positioned proximate to the lateral portions 3124 to direct airflow laterally from the user's face and avoid directing air toward the user's eyes. In some examples, the cantilever structure 3110 can be configured such that inhaled air can be drawn through the material, but only selected locations (or no locations) allow exhaled air to pass, eg, to avoid eye spray/eyeglass fogging. For example, cantilever structure 3110 may be configured as or include a one-way valve and may only allow inhaled air to enter chamber 3014, but may prevent exhaled air from leaving chamber 3014 (which may be expelled through body 3010 as described above). This can be accomplished by one or more flaps (apertures) that open during inhalation and close during exhalation. Another alternative may include auxetic material at certain locations (eg, near lateral portion 3124 ) that tends to cause closure of the passageway due to the slightly higher forces generated during exhalation. In other examples, at least some of the holes in the cantilever structure 3110 can be tapered such that the smaller diameter opening is inside the chamber 3014 and the larger diameter is outside the chamber 3014 on the outer surface of the body 3010 ( For example, on top surface 3128). Tapered ports 3030 may allow air to flow more freely in one direction (eg, inhaled air travels into chamber 3014 ) and flow more difficult in the opposite direction (eg, exhaled air out of chamber 3014 ). This is useful in accessing the upper portion of the chamber to limit airflow into the user's eyes.

As shown in Figures 10-1 and 12-1, the cantilever structure 3110 can allow the user to wear the mask 3000 more comfortably. As described above, the cantilever structure 3110 can seal against the perimeter 1100 of the user's nose (e.g., the outer nasal edge radius from the area near the pronasa to the posterior corner of the nose near the alar base) (e.g., when the user is in an upright position, lower than the user's nasal protuberance) and block or substantially block airflow, or may be semi-permeable and direct any exhaled air away from the user's eyes. In either case, substantially no exhaled air travels along the user's nasal ridge toward the user's eyes. Thus, users can avoid fogging up their glasses 1050 . In addition, since fogging of the glasses 1050 is not a significant problem for the cantilever structure 3110, the user can wear the glasses 1050 at a predetermined position. In other words, the user can be in a desired position (e.g., near the point of the bridge of the nose as shown in FIG. 12-1 ) and/or at a desired angle (e.g., the arm of the glasses 1050 against the user's ear as shown in FIG. 12-1 ). ) wears glasses 1050 . When using a cantilever structure, users may not need to distort their vision (eg, by tilting the lenses relative to their eyes) or position the glasses in uncomfortable positions (eg, overlapping part of the mask).

The foam may expand in a direction perpendicular to the applied force, which may cause the foam to partially or completely cover the user's nostrils. To limit this, the foam may not be overly compressible (eg, due to material properties and/or due to thickness). This helps limit the occurrence of blocked nostrils. Foam is comfortable to the user even when substantially incompressible. In some forms, the foam used to construct cantilever structure 3110 is generally stretchable. However, the thickness of the cantilever structure 3110 generally limits the overall length extension (eg, to limit the occurrence of clogging). The cantilever structure 3110 is still stretchable than the main body 3010, which serves to maintain the cup shape.

In some forms, the upper surface 3128 of the cantilever structure 3110 may be coated (eg, silicone coated) to increase impermeability. The coating can be substantially smooth and provide a comfortable feel to the user. In other forms, upper surface 3128 may remain uncoated, which may limit adhesion of cantilever structure 3110 to the user's face (eg, creating creases and folds where leaks may occur).

Of course, the cantilever structure 3110 can be made of other materials such as fabric. The cantilever structure 3110 composed of another material may have a similar thickness as the cantilever structure 3110 composed of foam. For example, cantilever portion 3110 may be constructed of substantially impermeable fabric, vinyl, silicone, thermoplastic polyurethane. These other materials may also have limited compressibility to limit obstruction of the user's nostrils in use. These materials may also have limited stickiness or adhesiveness to avoid sticking to the user's face.

As shown in FIGS. 7 through 8-1 , some form of foam (or other material used to construct cantilever portion 3110 ) is used along its entire length (e.g., from lateral portion 3124 to lateral portion 3124, or from lateral portion 3124 to center portion 3122) may comprise substantially the same thickness. In other forms, the foam (or other material) used to construct the cantilever structure 3110 may include varying thicknesses. The thickness may vary between lateral portions 3124 and central portion 3122 and/or between front edge 3120 and rear edge 3126 .

In some forms, the foam may be thickest between the central portion 3122 and the lateral portions 3124 (eg, the thickest portion may be proximate the maximum width 3140 and the thinnest portion may be proximate the central portion 3122 and the lateral portions 3124). The increased thickness of the foam near the maximum width 3140 can help the foam conform to the sharp corners of the user's face and ensure that the material of the cantilever portion 3110 completely fills the user's wing base area, which can limit leakage. The thinner areas near the central portion 3122 and/or the lateral portions 3124 can reduce irritation to more sensitive parts of the user's skin. In other forms, the varying thicknesses may be reversed (ie, such that maximum width 3140 is thinner than central portion 3122 and/or lateral portions 3124).

In some forms, the foam may be thicker near the front edge 3120 and thinner near the rear edge 3126 . Thinner material closer to the user's nostrils may be more comfortable. However, other forms may have a thicker portion near the rear side 3126, which may provide a better seal.

In use, the cantilever portion 3110 contacts the lower surface of the user's nose around the perimeter 1100 . As shown in FIGS. 9 and 9-1 , the flanges of the user's nose may contact the cantilever portion 3110 between the central portion 3122 and the corresponding lateral portion 3124 . The user's nose may apply a contact force to the cantilever portion 3110, which may cause the cantilever portion 3110 to bend in a downward direction. For example, cantilever portion 3110 may bend into chamber 3014 due to contact with the user's nose. The elastic properties of the material used to construct the cantilever portion 3110 can resist contact forces from the user's nose. This can create the necessary seal against the user's nose. The seal between the cantilever portion 3110 and the user's face limits leakage of air in the chamber 3014 around the outer perimeter 3012 . The combination of the low permeability of the cantilever portion 3110 and the seal between the user's face and the cantilever portion 3110 can direct airflow through the body 3010 . In some forms, about 50% to about 100% of inhaled and exhaled airflow passes through body 3010 . In some forms, about 75% to about 100% of inhaled and exhaled airflow passes through body 3010 . In some forms, about 90% to about 100% of inhaled and exhaled airflow passes through body 3010 . In some forms, approximately 95% of inhaled and exhaled airflow passes through body 3010 . In some forms, approximately 100% of inhaled and exhaled airflow passes through body 3010 . In other words, inhaled and exhaled air can follow the path of least resistance. Because the body 3010 has low permeability and the body 3010 does not seal against the user's face, airflow can enter and exit the chamber in a front-to-back direction and is restricted from traveling in an up-down direction (eg, by the cantilever portion 3110).

Restricting airflow in an up and down direction can help keep airflow away from the user's eyes. Directing exhaled air forward rather than upward can be particularly helpful in reducing irritation for the user. Due to the heat transfer that occurs within the user's airway, the temperature of the exhaled air may be higher than the temperature of the inhaled air. This warm exhaled air may condense on solid surfaces at cooler air temperatures (for example, if the air temperature in the user's environment is lower than that of the exhaled air). This may be particularly irritating to the user wearing the glasses 1050 (eg, exhaled air may condense on the surface of the glasses 1050, which may be cooler than the temperature of the exhaled air). This may limit the user's vision. Even if the user is not wearing glasses, the warm exhaled air may dry out the user's eyes and cause irritation. Directing the airflow away from the user's eyes limits this problem.

Even if some air did pass through the cantilever portion 3110, or between the cantilever portion 3110 and the user's face, the airflow would not be directed toward the user's eyes. The central portion 3122 contacts the user's nose proximate or adjacent to the user's nasal protuberance. But the central portion 3122 does not extend beyond the tip of the user's nose, nor does it extend along the bridge of the user's nose. In other words, the central portion 3122 contacts the user's nose along the sagittal plane at a location below the pronata, although the central portion may contact the user's columella at a location adjacent to the user's pronata. Thus, the direction above the cantilever portion 3110 is at least partially in front of the user's eyes (eg, airflow can pass above without entering the user's eyes). Additionally, by not extending along the user's nasal ridge (eg, avoiding any contact with the user's nasal ridge), the cantilever portion 3110 is not used to direct air (eg, exhaled air) rearwardly along the user's nasal ridge. However, in a form extending along the nose ridge, the cantilevered portion 3100 (or other structure) may provide a snug fit so as to limit airflow toward the user's eyes.

In other forms, cantilever portion 3110 includes the highest impedance while the remainder of mask 3000 (eg, body 3010 and mouth seal 3104 ) includes lower impedance. These lower impedances may be the same or different (eg, the impedance of the mouth seal 3104 may be between the impedance of the cantilever portion 3110 and the body 3010). Airflow may follow the path of least resistance and is more likely to pass through body 3010 and/or mouth seal 3104 than cantilever portion 3110 . In this way, airflow (eg, particularly warm exhaled air) is less likely to flow towards the user's eyes, but will instead flow in a forward and downward direction away from the user's face.

In other forms, the cantilever portion 3110 may be at least partially permeable (eg, less permeable than the inner surface 3032 of the body 3010). Airflow (eg, exhaled air) can pass through the cantilever portion 3110, but the reduced permeability of the cantilever portion 3110 (eg, compared to the main body 3010) can help diffuse the air. For example, the entire flow of exhaled air through the cantilever portion 3110 may not be directed in a common direction (eg, toward the user's eyes). This can also help improve user comfort (eg, by limiting irritation in and/or around the user's eyes).

5.2.2 Mouth sealing part

5.2.2.1 Nozzle sealing member

As shown in FIGS. 4 and 8 , some versions of the mask 3000 may include a mouth seal 3104 extending from a nose seal 3102 that surrounds the sides of and under the user's mouth. Together, nose seal 3102 and mouth seal 3104 may form a substantially complete seal around outer perimeter 3012 of body 3010 .

In some forms, portion 3130 of mouth seal 3104 is formed by cantilever structure 3110 (eg, by the portion of rear edge 3126 of cantilever structure 3110 between maximum width 3140 and lateral portion 3124 ). As shown in FIG. 9, the portion 3130 of the cantilever structure 3110 that seals around the user's mouth may extend from an area directly below the user's nose to the sides of the mouth area. For example, portion 3130 of cantilever structure 3110 may extend from an area of the user's face near the base of the wings toward the nasolabial fold. In some forms, portion 3130 may not extend above or below the user's lips in use. In an example, the seal-forming structure 3100 does not seal against the area on the lips directly under the user's nasal septum and below the nostrils. In this way, the user is not prevented from breathing through their nose into the chamber.

In some forms, mouth seal 3104 includes portion 3132 configured to seal around a lower portion of the user's face. For example, portion 3132 may seal between the chin and under the lip, and may extend between lateral portions 3124 of cantilever structure 3110 . This can make the mask 3000 appear less bulky than a mask that extends under the user's chin because the mouth seal 3104 has a smaller footprint on the user's face.

However, some masks (not shown) may contact the user's chin (e.g., near the user's chin) and/or extend under the user's chin (e.g., below the user's chin) so as to Provides additional coverage.

In some forms, portion 3132 may be constructed from a single piece of material. Portion 3132 may be attached to outer perimeter 3012 of body 3010 in a similar manner as cantilever structure 3110 (eg, by gluing, ultrasonic welding, mechanical fasteners, magnets, etc.). Once attached to body 3010, portion 3132 may comprise an arcuate shape (e.g., a semi-elliptical shape) that will go from one nasolabial fold, laterally outside the user's mouth to under the lips, and to the opposite nasolabial fold, Touch the user's face. In other forms, portion 3132 may be constructed from two pieces of material. The two portions may join at a substantially central axis of the body 3010 (eg, substantially in line with the central portion 3122 in the inferior-superior direction).

In some forms (see, eg, FIGS. 11A and 11B ), portion 3132 may not extend from body 3010 in a cantilevered manner. In other words, portion 3132 may not extend into chamber 3014 . Alternatively, portion 3132 may extend substantially perpendicularly from body 3010 (eg, towards the user's face in use). Contact with the user's face may compress portion 3132 (eg, in the front direction) into body 3010 .

As shown in FIG. 8 , some forms of portion 3132 may be configured as a flange 3134 extending from the perimeter of body 3010 . Additionally or alternatively, a portion of the mouth seal 3104 may include the perimeter of the body 3010 if the body 3010 is made of a suitable material, such as a suitable fabric or foam.

In some forms, the thickness of portion 3132 (eg, measured in a direction generally perpendicular to the body) may be substantially small such that mask 3000 does not extend a significant distance from the user's face and does not obstruct the user's view. In some forms, portion 3132 may be between about 1 mm and about 50 mm thick. In some forms, portion 3132 may be between about 2 mm and about 40 mm thick. In some forms, portion 3132 may be between about 3 mm and about 30 mm thick. In some forms, portion 3132 may be between about 4 mm and about 20 mm thick. In some forms, portion 3132 may be between about 5 mm and about 10 mm thick.

As shown in FIGS. 4 and 8 , some form of nose seal 3102 may be incorporated or blended into mouth seal 3104 . In other words, cantilever structure 3110 may be fused into portion 3132 such that the two portions of seal-forming structure 3110, 3132 are connected across a substantially smooth transition.

As mentioned above, the cantilever structure 3110 can be connected to the main body 3010 along the front edge 3120 . Specifically, front edge 3120 may be in direct contact with body 3010 (eg, near outer perimeter 3012). As shown in Figure 8, the cantilever structure 3110 may extend over the chamber 3014 and may extend in a rearward direction during use.

As shown in FIGS. 4 and 8 , the cantilever structure 3110 decreases in width near the lateral portion 3124 . In other words, the distance between rear edge 3126 and front edge 3120 decreases. Accordingly, rear edge 3126 may converge toward front edge 3120 . As the width between front and rear edges 3120 , 3126 decreases, the width of cantilever portion 3110 becomes closer to portion 3132 . In other words, lateral portion 3124 has substantially the same thickness as portion 3132 . Cantilevered portion 3110 may transition smoothly into portion 3132 . For example, there is a non-discontinuous transition (eg, non-stepped) between lateral portion 3124 and portion 3132 . This can be assisted by the curved shape of the lateral portion 3124, which allows for a smooth transition.

As shown in FIG. 8 , some forms of mask 3000 may include an angle between portion 3132 and cantilever structure 3110 . While the interface between portion 3132 and cantilever structure 3110 may be smooth (eg, with minimal or no sharp corners), the interface may not be perfectly circular. The angle between the proximal end of portion 3132 and cantilever structure 3110 may be an obtuse angle measured between rear edge 3126 and flange 3134 . The angle 3150 between the portion 3132 and the cantilever structure 3110 may correspond to the angle of the user's face near the nasolabial fold. In some forms, the angle 3150 may be between about 91° and about 179°. In some forms, the angle 3150 may be between about 110° and about 175°. In some forms, the angle 3150 may be between about 130° and about 170°. In some forms, the angle 3150 may be between about 155° and about 165°. In some forms, the angle 3150 may be about 165°. Angle 3150 may be close to 180° because facial features close to a user's nasolabial folds may be close to vertical in some users. The mask can be adjusted (eg, by bending) to provide some adjustment for different users, so that a single mask can fit a wide range of users. Alternatively, multiple sizes of mask 3000 may be manufactured, including on each size of mask 3000 different angles within the ranges described above.

Portion 3132 and cantilever structure 3110 may be connected to body 3010 adjacent to each other such that there is substantially no gap between portion 3132 and lateral portion 3124 . In some forms, lateral portion 3124 may be directly coupled to portion 3132 , which may reduce leakage from chamber 3014 . Portion 3132 and cantilever structure 3110 can be coupled together in an end-to-end configuration to form a substantially sealed interface (eg, a hygienic mask mass-sealed interface). However, such examples may include a small gap (eg, less than about 5 mm) between the proximal end of portion 3132 and cantilever structure 3110 . In some forms, a shorter cantilever structure 3110 (eg, shortened by no more than about 15 mm) may be used with an accompanying longer portion 3132 (eg, no more than about 15 mm longer). The shorter cantilever structure 3110 can still press against the cheek area for a hygienic mask quality seal.

In some forms, cantilever portion 3110 and portion 3132 may be constructed of substantially the same material. This can improve user comfort, as the user will not perceive significant differences between portions 3110,3132.

In some forms, cantilever portion 3110 and portion 3132 may be constructed from the same piece of material such that cantilever portion 3110 and portion 3132 are a one-piece construction.

In some forms, portion 3132 may be coupled to body 3010 in a one-piece and/or unitary construction. Cantilever portion 3110 may be connected to portion 3132 and/or body 3010 in a one-piece and/or unitary construction.

In some versions where mask 3000 is used with a patient interface to treat a breathing disorder (eg, using CPAP therapy to treat sleep-disordered breathing), mouth seal 3104 may not be included. For example, while some forms of patient interfaces may include a full face seal (i.e., nose seal 3102 and mouth seal 3104), some forms of patient interfaces may include only nose seal 3102, and may only seal around the user's nostrils. For example, nose seal 3102 may seal against the flange and upper lip, and may not contact the lower lip. In this form, the user's mouth is not exposed to pressurized air, but remains in the surrounding environment.

5.2.2.2 Body forming mouth seal

As shown in FIGS. 17-22, some versions of the mask 3000 may not include a separate sealing structure (eg, a foam flange 3134 extending from the body 3010) for sealing at least partially around the user's mouth.

These versions of the mask 3000 may include substantially the same cantilever structure 3110 as described above. For example, portion 3130 of mouth seal 3104 may be formed by cantilever structure 3110 (eg, by the portion of rear edge 3126 of cantilever structure 3110 between maximum width 3140 and lateral portion 3124 ). As shown in FIGS. 20-22, the portion 3130 of the cantilever structure 3110 that partially seals around the user's mouth may extend from an area directly below the user's nose to the sides of the mouth area. The nose seal 3102 may have approximately the same dimensions as the nose seal 3102 of FIG. 9 so that it contacts the same area of the user's face. For example, portion 3130 of cantilever structure 3110 may extend from an area of the user's face near the base of the wings toward the nasolabial fold. In some forms, portion 3130 may not extend above or below the user's lips in use. In an example, the seal-forming structure 3100 does not seal against the area on the lips directly under the user's nasal septum and below the nostrils. In this way, the user is not prevented from breathing through their nose into the chamber.

However, the mask 3000 shown in FIGS. 20-22 may not include portion 3132 . For example, mask 3000 may not include foam extending completely around the perimeter of body 3010 . The foam material may stop at lateral portion 3124 and the material (eg, fabric) of body 3010 may be exposed.

As noted above, portion 3132 of mask 3000 shown in FIGS. 8 and 8-1 may have a substantially small thickness. For example, the curvature near lateral edge 3124 may merge rear edge 3126 into front edge 3120 such that there is substantially no thickness between edges 3120 , 3126 . Accordingly, removal of portion 3132 in mask 3000 shown in FIGS. 20-22 may not create a noticeable gap between body 3010 at lateral edge 3124 and the user's face when mask 3000 is worn. Additionally, there may also be no appreciable gap between the main body 3010 and the underside of the user's lips when the mask 3000 is worn.

As shown particularly in FIGS. 21 and 22, the thickness of the cantilever structure 3110 may be incorporated into the surface of the ring 3302 of the positioning and stabilizing structure 3300 (described below). As described above with respect to the example shown in FIG. 8 , rear edge 3126 may include a smooth curve such that it gradually transitions into the surface of ring 3302 . In some forms, there may be substantially no edges or corners between the rear edge 3126 of the cantilever structure 3110 and the surface of the ring 3302 . This allows the mask 3000 to be worn comfortably by the user as the rear edge 3126 contacts the user's face in use.

In some forms, the user's face may directly contact body 3010 and/or positioning and stabilizing structure 3300 without portion 3132 . In particular, the user's face may contact the positioning and stabilizing structure 3300 . As described in more detail below, a surface of positioning and stabilizing structure 3300 (eg, a surface of ring 3302 ) may restrict airflow into chamber 3014 and/or may form a seal against the user's face.

5.3 Filter elements

As noted above, some forms of the body 3010 may include a permeable portion through which air may pass. In some forms, the permeable portion can be used to filter air passing through the permeable portion to a sufficient extent that additional filtering (eg, by a specific filter element) is not required. However, in instances where the mask 3000 is configured as a multipurpose hygiene mask and/or requires a greater degree of filtration than is provided by the material of the permeable portion alone, the mask 3000 may be provided with an additional filter element 3024 (see, e.g., 13 to 14-2) The filter element 3024 can have a lower permeability than the main body 3010 of the mask 3000 so that fewer particles or debris can enter the chamber 3014 and be inhaled by the user, and/or allow the Fewer particles can leave chamber 3014 after gas. The lower permeability may not substantially affect airflow into and/or out of the chamber (ie, filter element 3024 may not adversely affect the user's breathing).

In some forms, filter element 3024 may be configured to attach to fastener 3026 on interior surface 3032 within chamber 3014 . As noted above, the fasteners 3026 may be hook and loop fasteners or any other suitable fasteners. Filter element 3024 may have corresponding fasteners (not shown) that removably engage fasteners 3026 . While some forms of filter element 3024 can be attached to fastener 3026 without a separate corresponding fastener (eg, the material of filter element 3024 includes loop material engageable with the hook and loop material of fastener 3026). The inner surface 3032 may include different amounts of fasteners 3026 (e.g., depending on the type of fasteners 3026 and/or whether the filter element 3024 includes corresponding fasteners) in order to provide an appropriate level of engagement with the filter element 3026 . For example, the inner surface 3032 of FIGS. 20 and 21 may include a greater number and longer length of fasteners 3026 than the inner surface 3032 of FIG. 8 . In other forms, filter element 3024 may be coupled to an exterior surface of body 3010 (eg, positioned outside chamber 3014). The filter element 3024 can be coupled to the outer surface in substantially the same manner as the filter is coupled to the inner surface 3032 (eg, using at least one fastener).

In some forms, the triangular (or diamond) shape of the fastener 3026 of FIGS. 20 and 21 may contact the filter element 3024 around the outer perimeter. This helps to better secure the filter element 3024 in place during use.

Some forms of filter element 3024 may be positioned within recess 3046 as shown in FIG. 13-1 . Recess 3046 may be sized to receive filter element 3024 snugly. In some forms, the recess 3046 may include a resilient portion to help retain the filter element. In some forms, the recess 3046 alone may be sufficient to retain the filter element 3024 during use. However, as shown in Figure 13-2, fasteners 3026 may be used with dimples 3046 to provide additional retention.

In either case, the attached filter element 3024 can provide additional stiffness to the mask 3000. In other words, the filter element 3024 can provide additional stiffness to the body and act as an additional rigidity to help maintain the three-dimensional shape (eg, cup shape) of the body 3010 . Filter element 3024 may be formed from a rigid or semi-rigid material so as to act as a rigid member.

In some forms, the filter element 3024 can be reusable and can be disconnected from the body 3010 (eg, after each use) and cleaned before being reattached to the fastener 3026 .

In other forms, the filter element 3024 may be disposable and may be disposed of after each use. The user can attach a new clean filter element 3024 before each use.

In some forms, filter element 3024 may be shaped to substantially correspond to the shape of body 3010 (see, eg, FIG. 13 ). For example, the shape of filter element 3024 may substantially correspond to the shape of outer perimeter 3012 . The filter element 3024 can be positioned against the inner surface 3032 of the body 3010 such that it is at least partially covered by the cantilever element 3110 . In other words, the user can position filter element 3024 below cantilever structure 3110 such that filter element 3024 can extend to outer perimeter 3012 and can not interfere with the seal between the user's face and cantilever structure 3110 . Filter element 3024 may be constructed of a substantially flexible material such that a user may bend or otherwise reposition filter element 3024 such that it fits around cantilever structure 3110 . The rigidity of the body 3010 can help maintain the separation between the filter element 3024 and the user's airway so as to reduce the breathing resistance experienced by the user.

In some forms, filter element 3024 may be formed from a semi-rigid material (eg, so as to act as a rigid body for maintaining the three-dimensional shape of body 3010), but may be bendable or manipulable by a user. This may allow the user to position the filter element 3024 around the cantilever structure 3110 while still allowing rigid support of the body 3010 in use.

In some versions similar to FIG. 15 , filter element 3024 may sit flush against inner surface 3032 when attached to fastener 3026 . Accordingly, the filter element 3024 may not take up substantially the volume of the chamber 3014, and the user's skin may avoid contact with the filter element 3024 in use.

In some forms, the filter element 3024 can be more rigid around the periphery than near the center. For example, Figures 14-1 and 14-2 illustrate a rigid member 3025 that can be coupled to the outer perimeter of the filter element 3024, which can help the filter element 3024 maintain its shape. Although more rigid than the center of filter element 3024, rigid member 3025 may be malleable so that the shape of filter element 3024 may be adjusted by a user. For example, the user can adjust the shape of the main body 3010 and the cantilever portion 3110, as shown in FIGS. 11A and 11B. The user may also adjust the shape of the filter element 3024 so that it continues to fit flush over the modified shape of the main body 3010 and/or cantilever portion 3110 .

In one form, rigid member 3025 may be elastic and capable of returning to a neutral portion when no external force is applied. For example, a user can bend filter member 3024 to fit within chamber 3014 (see, eg, FIG. 14-1 ). After the filter member 3024 is positioned in the desired orientation, the rigid member 3025 can be returned toward its neutral position (see, eg, FIG. 14-2 ). In other words, the filter member 3024 can expand toward the outer perimeter 3012 of the body 3010 . The filter member 3024 can substantially or completely cover the inner surface 3032 of the body 3010 and can restrict airflow from bypassing the outer edges of the filter member 3024 (eg, and not being filtered).

In some forms, the rigid member 3025 of the filter element 3024 can be more elastic than the deformable object 3028 coupled to the body 3010 .

In examples where the body 3010 is provided with ports (eg, see FIG. 5-1 ), holes, or vents 3030, the filter element 3024 may be configured to extend only through or within these ports, holes, or vents. The vent extends inside. The fastener may be disposed proximate the port, hole or vent 3030 such that the filter element 3024 may be positioned to directly cover the port, hole or vent 3030 . In other examples, filter element 3024 may be configured to cover the entire interior surface of body 3010 .

In one example, the filter element comprises substantially the same material as used in prior art surgical masks.

In addition to collecting debris, bacteria, and/or other particles that the user does not want to inhale or does not want others to inhale, the filter element 3024 can also prevent droplets from contacting the body 3010 . Filter element 3024 can protect body 3010 and keep body 3010 relatively clean. This may allow a user to replace only the filter element 3024 and continue to use the body 3010 for multiple uses without cleaning.

In some forms, filter element 3024 may include an electrical charge to help capture debris. For example, fragments can have a negative charge. The filter element may have a positive charge in order to attract negatively charged debris. Alternatively, filter element 3024 may have a negative charge in order to attract positively charged debris.

5.4 Positioning and stabilizing structures

As shown in Figures 7, 8 and 12, the mask 3000 is provided with a positioning and stabilizing structure or headgear 3300 which helps to maintain the body 3010 and seal-forming structure 3100 in an in-use position against the user's face. Positioning and stabilizing structure 3300 may provide a force (eg, sealing force) directed at least partially in a posterior direction to provide sufficient contact and sealing force between seal-forming structure 3100 and the user's skin.

As shown in FIG. 12, some forms of headgear 3300 are formed as a headgear and include loops 3302 that wrap around the user's ears and hold the mask 3000 in place. Each ring 3302 may form a complete perimeter (ie, no breaks or breaks in the material). This helps limit ring 3302 from tangling. Ring 3302 may be made of a suitably resilient fabric or foam (eg, resilient foam). This may allow the loop 3302 to expand and expand as the user puts on and/or takes off the mask 3000 to fit different sized ears. This may also allow the ring 3302 to return to a relaxed state when the mask 3000 is in use, such that the ring 3302 contacts the user's ear and provides a sealing force.

As shown in FIG. 12, some form of loop 3302 may contact the user's face when engaged to the user's ear. For example, each ring 3302 may rest on the corresponding user's cheek below the user's eyes (eg, the rings do not protrude significantly from the user's cheek and may be considered to be substantially flush with the user's face). The material of ring 3302 may be substantially thin so as not to obstruct the user's view. Thinner materials have less resistance to stretching, so thinner materials can also allow the ring 3302 to stretch more easily.

In some forms, loop 3302 may be the most extended portion of mask 3000 . In other words, loop 3302 can extend the maximum length of any portion of mask 3000 under tension. Stretchability helps maximize the fit range of the mask 3000 (ie, increases the ability to wear the same size mask 3000 on different sized heads). The thickness of each loop 3302 can be minimized to provide maximum stretchability while providing sufficient strength (eg, such that the loops 3302 do not break when tension is applied).

In some forms, each ring 3302 may be constructed of a foam material having a thickness between about 0.1 mm and about 10 mm. In some forms, each ring 3302 may be constructed of a foam material having a thickness between about 1 mm and about 5 mm. In some forms, each ring 3302 may be constructed of a foam material having a thickness between about 1.5 mm and about 4 mm. In some forms, each ring 3302 may be constructed of a foam material having a thickness of about 2 mm.

In some forms, each ring 3302 may be constructed of a fabric (eg, woven fabric) material having a thickness between about 0.1 mm and about 10 mm. In some forms, each ring 3302 may be constructed of a fabric (eg, woven fabric) material having a thickness between about 0.5 mm and about 5 mm. In some forms, each ring 3302 may be constructed of a fabric (eg, woven fabric) material having a thickness between about 0.75 mm and about 4 mm. In some forms, each ring 3302 may be constructed of a fabric (eg, woven fabric) material having a thickness of about 1 mm.

As shown in Figures 5-6, 12, and 17, some forms of ring 3302 may include an elongated and/or substantially oval shape. For example, the upper and lower sides of each ring 3302 can be substantially parallel to each other. The distance between the upper edge of the upper side and the lower edge of the lower side is approximately equal to the height of the body 3010 . In other words, the footprint of the ring 3302 in the lower-upper direction may be substantially the same as the footprint of the body 3010 in the same direction.

As shown in FIGS. 5 through 5-2, some forms of the ring 3302 are configured to connect to or engage substantially the entire perimeter 3012 of the body 3010, or at least a majority of the perimeter 3012 of the body 3010, rather than in narrower or more localized areas. Attached to the main body 3010 at a point. The positioning of ring 3302 may help reduce or eliminate wrinkling of body 3010 , particularly at portions of body 3010 that form part of seal-forming structure 3100 .

In some forms, the headband 3300 is attached to the inner perimeter 3136 of the lower half of the body 3010 forming at least a portion of the mouth seal portion 3104 of the seal-forming structure 3100 . In an example, the headgear 3300 is attached to the main body by adhesive (eg, glue, tape, or a combination of glue and tape), ultrasonic welding, stitching, mechanical fasteners, or any similar attachment means. Adhesives may also be used to increase the rigidity of mask 3000 (eg, adhesives may serve as rigidizers). In other forms, the headgear 3300 may be connected to the body 3010 by a one-piece and/or integral connection (eg, constructed from the same piece of material so that an attachment device is not required).

In some forms, headgear 3300 may be coupled to body 3010 proximate front edge 3120 and upper surface 3128 . As shown in FIGS. 7 , 12 and 19 , headgear 3300 may include upper arms 3306 and lower arms 3308 on either side of mask 3000 . Each upper arm 3306 can be connected to an upper portion of body 3010 (eg, proximate cantilever portion 3110 ), and each lower arm 3308 can be connected to a lower portion of body 3010 (eg, proximate portion 3132 ). The upper arm 3306 and the lower arm 3308 on either side (eg, left and right) can be formed as a single piece of material and can be joined together to form the loop described above.

As shown in FIGS. 9 , 9-1 and 22 , some form of upper arm 3306 may be attached to edge 3036 of body 3010 . Edge 3036 may form the outer boundary of outer perimeter 3012 . Edge 3036 may also be oriented substantially perpendicular to inner surface 3032 . Accordingly, upper arm 3306 may be oriented proximate upper surface 3128 of cantilevered portion 3110 . Adhesive (eg, glue, tape, or a combination of glue and tape), ultrasonic welding, sewing, mechanical fasteners, or any similar means of attachment may be applied to each upper arm 3306 and/or edge 3036 . Any of these attachment means also serve to increase the rigidity of the mask 3000 (eg, adhesives can be used as rigidizers).

As shown in FIG. 22 , front edge 3120 of cantilever structure 3110 can be connected to ring 3302 such that at least a portion of cantilever structure 3110 can be perpendicular relative to positioning and stabilizing structure 3300 (eg, when mask 3000 is not in use). In particular, the upper arm 3306 of each ring 3302 may be connected to the body 3010 as described above. Cantilever structure 3110 can extend substantially perpendicularly relative to upper arm 3306 such that cantilever structure 3110 protrudes toward the user's face, which can help provide proper contact when mask 3000 is worn by the user.

With continued reference to FIGS. 9 and 9-1 , some form of each upper arm 3306 can extend in a direction that is substantially parallel to at least a portion of the cantilevered portion 3110 (eg, near maximum width 3140 ). In some forms, each upper arm 3306 can be substantially tangent to a portion of the cantilever portion 3110 (eg, to the central portion 3122 ). In some forms, upper arms 3306 may be spaced apart from each other (eg, not connected at central portion 3122).

In some forms, the upper edge 3310 of each upper arm 3306 can be substantially linear. As shown in FIG. 7 , the width of each upper arm 3306 can decrease toward central portion 3122 such that each upper arm 3306 can merge into body 3010 (eg, edge 3036 ). Upper edge 3310 of each upper arm 3306 can be substantially collinear with edge 3036 . Accordingly, upper arms 3306 do not significantly increase the footprint of mask 3000 . The linear shape of the upper edge 3310 can also help direct the sealing force up and into the user's face.

In some forms (see FIG. 6 ), upper arm 3306 and/or lower arm 3308 may taper along their length. For example, upper arm 3306 and/or lower arm 3308 may be wider closer to body 3010 and may decrease in width away from body 3010 . A wider portion near the body 3010 can help form a better connection (e.g., a larger connection surface area) between the body 3010 and the arms 3306, 3308 and/or increase stability between the body 3010 and the arms 3306, 3308 sex. The narrower portions of the arms 3306, 3308 can help increase user comfort. For example, thinner arms 3306, 3308 result in less surface area contacting the user, which can reduce the source of irritation. Additionally, the narrowest portions of the arms 3306, 3308 may extend around the user's ears in use. This helps to provide a force that is less likely to cause irritation to the back of the user's ear.

As shown in FIG. 7 , the lower arm 3308 may be connected to the main body in a similar manner as the upper arm 3306 . For example, lower arm 3308 may also be attached (by adhesive, ultrasonic welding, stitching, mechanical fasteners, or any similar attachment means) to edge 3036 . Lower arm 3308 may be coupled to edge 3036 in an orientation that is substantially perpendicular to portion 3132 coupled to inner surface 3032 . Any of these attachment means also serve to increase the rigidity of the mask 3000 (eg, adhesives can be used as rigidizers).

As shown in FIG. 21, any seams formed by connecting the lower arm 3308 to the main body 3010 are not exposed. In other words, the seam created by the attachment method can be between the main body 3010 and the lower arm 3308 such that the user does not touch the seam. This may be particularly beneficial when portion 3132 is omitted and the user is in direct contact with lower arm 3308 (eg, there is a smoother surface that would reduce irritation to the user's skin).

As shown in FIG. 8 , some form of end portions of the lower arm 3308 may be connected to the main body 3010 proximate to each other. For example, the ends of the lower arms 3308 may contact each other.

With continued reference to FIG. 8 , some forms of the lower arm 3308 may include a slight bend 3312 . In other words, the lower edge 3314 of each lower arm 3308 may not be completely linear (eg, include two sloped portions, for example). The bend 3312 can be oriented to the lower edge 3314 such that it is substantially parallel to the upper edge 3310 and the upper and lower arms 3306, 3308 direct the sealing force in substantially the same direction.

Referring to Figures 17-22, positioning and stabilizing structure 3300 may help provide adequate contact between mask 3000 and the user's face. As noted above, this form of mask 3000 does not include structures for sealing the sides or bottom of the user's mouth (eg, sealing the user's lower lip). Therefore, sealing at the lower end of the mask 3000 may be omitted entirely. For example, air leaking from chamber 3014 in a downward direction (eg, when the user is standing upright) is less likely to cause user irritation (eg, air is not directed into the user's eyes or glasses). Users will also feel more comfortable if there is no seal under their lips. In some forms, the positioning and stabilizing structure 3300 can hold the body 3010 snugly under the user's lips without creating a seal. The nose seal 3102 may still prevent fluid flow in an upward direction, but the material of the nose seal 3102 (eg, foam) may not be effective in sealing the chamber 3014 .

In some forms, most of the air inhaled by the user can still pass through the filter element 3024 (if used). Any gap between the user's lip and the positioning and stabilizing structure 3300 may be small so that a limited amount of unfiltered air enters the chamber 3014 in that direction. Additionally, the user's mouth and nose may be positioned proximate to the filter element 3024 such that most of what is inhaled into the chamber 3014 is inhaled after passing through the filter element 3024 first. This can help reduce the effects of an incomplete seal around the entire sealing perimeter 1105 . In other words, the mask 3000 can continue to help the user limit the inhalation of debris and other unwanted particles even without forming a perfect seal.

In other examples of FIGS. 17-22 , positioning and stabilizing structure 3300 may provide a sealing force capable of forming a seal around the entire sealing perimeter 1105 . Although the lower portion of the mask 3000 may not include a portion 3132 for sealing against the user's lips, the material of the lower portion of the mask 3000 may be sufficiently impermeable to form a seal.

For example, the positioning and stabilizing structure 3300 (or at least the lower arm 3308 of the ring 3302) can be substantially impermeable (eg, constructed of or coated with an impermeable material). As shown in FIGS. 8 and 8-1 , portion 3132 overlaps at least a portion of lower arm 3308 . Thus, the lower arm 3308 covers the sublip region of the user. For example, the lower arm 3308 may directly contact the user under the lip and between the chin bump. Returning to the example of FIGS. 18-22 , when portion 3132 is removed, lower arm 3308 may be positioned adjacent or in contact with the user's underlip (since there is no longer an intermediate structure).

As noted above, the lower arm 3308 may be formed from a comfortable material to limit irritation to the user. Instead of portion 3132, lower arm 3308 (or all loops 3302) may be made of foam and/or fabric material to provide cushioning for the user's face. For example, lower arm 3308 may be thicker than the rest of ring 3302 to provide cushioning to the user without portion 3132 . Additionally, the seams can be hidden to limit irritation to the patient.

Applying sufficient force with the positioning and stabilizing structure 3300 can pull the lower arm 3308 into sublip contact with the user in a manner similar to how portion 3132 contacts the sublip of the user. Because inner arms 3308 are impermeable, they can complete the perimeter (eg, with cantilever structure 3110 ) to form a complete seal around seal perimeter 1105 .

Due to the force from the positioning and stabilizing structure 3300, the material of the lower arm 3308 can be pressed against the user's face in order to limit discomfort caused by wearing the mask 3000. This can provide a cushioning effect upon contact with the user's face, which can replicate the feel of portion 3132 and provide a seal against the user's face.

As noted above, rear edge 3126 of cantilever structure 3110 may merge into the surface of ring 3302 without portion 3132 . As shown in FIG. 22, the curve of rear edge 3126 may be substantially smooth. This can limit any gaps (ie, sources of leakage) between the user's face and the surface of the ring 3302 when the user is wearing the mask 3000 .

As noted above, the lower arm 3308 may generally contact the user's face between the user's lips and chin. However, some masks (not shown) may contact the user's chin (e.g., near the user's chin) and/or extend under the user's chin (e.g., below the user's chin) so as to Provides additional coverage.

In another form, ring 3302 may be provided with a slide adjuster (not shown) to allow adjustment of the effective size of the ring. This may allow ring 3302 to be made from a less elastic material. Instead, the user can move the adjuster away from the body 3010 (eg, toward the free end of each loop 3302 ) so that the loops are larger than their ears to put on and/or take off the loops 3302 . The user then moves the adjuster toward the body 3010 (eg, toward the end secured to the body 3010 ) to adjust the size of the rings 3302 so that they provide sufficient sealing force and sufficient comfort.

In another form, headgear 3300 may include a pair of upper straps and a pair of lower straps. Both the upper and lower straps are connected to the main body 3010 . However, each upper strap is not connected to a corresponding lower strap to form a loop. In other words, the respective upper and lower straps do not have a complete piece of material. Instead, users can tie the straps together to form a loop. Users can form knots with selected lengths to vary the loop size. The upper straps can also be tied together and the lower straps can be tied together. In other words, the attached upper strap may contact the back of the user's head covering the parietal bones, and the attached lower strap may contact the back of the user's head covering the occipital bones.

In other forms of the technology, for example, if the mask 3000 is configured for use as a CPAP patient interface, alternative forms of positioning and stabilizing structures may be used, such as a headgear comprising one or more straps extending around the patient's head. Conduits that deliver air into chamber 3014 can also be used as straps.

5.5 Glossary

5.5.1 General

Air: In some forms of the technology, air may be taken to mean atmospheric air, and in other forms of the technology, air may be taken to mean some other combination of breathable gases, such as oxygen-enriched air.

Leak: The word leak will be considered an undesired air movement. In one example, leakage may occur due to an incomplete seal between the mask and the user's face. In another example, a leak may occur in a swivel elbow to the surrounding environment.

5.5.1.1 Materials

Fiber: A filament (monofilament or multifilament), ply, yarn, thread, or twist that is substantially longer than its width. Fibers may include: animal-based materials, such as wool or silk; plant-based materials, such as linen and cotton; and synthetic materials, such as polyester and rayon. A fiber may specifically refer to a material that may be interwoven and/or interlaced (eg, in a network) with other fibers of the same or different material.

Fabric: A material comprising at least one natural or man-made fiber. In this specification, fabric may refer to any material formed as a network of interwoven and/or interwoven fibers. One type of fabric can include fabrics, which are constructed by interweaving these fibers using specific techniques. These include weaving, knitting, crocheting, knotting, weaving, tufting or weaving. Cloth may be used synonymously with fabric, although may specifically refer to processed pieces of fabric. Other types of fabrics can be constructed using bonding (chemical, mechanical, thermal, etc.), felting, or other nonwoven processes. Fabrics produced by one of these methods are fabric-like and may be considered synonymous with fabric for purposes of this application.

5.5.1.2 Mechanical properties

Resilience: The ability of a material to absorb energy when elastically deformed and release energy when unloaded.

Resilient: Will release essentially all of its energy when unloaded. These include, for example, certain silicones and thermoplastic elastomers.

Hardness: A material's inherent resistance to deformation (as described, for example, by Young's modulus or an indent hardness scale measured on a standardized sample size).

• "Soft" materials may comprise silicone or thermoplastic elastomers (TPE), and may change easily eg under finger pressure.

• "Hard" materials may include polycarbonate, polypropylene, steel or aluminium, and may not deform easily eg under finger pressure.

Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. A load can be a force or moment, such as compression, tension, bending, or torsion. Structures or components can provide different resistance in different directions. The inverse of stiffness is compliance.

Flexible structure or part: A structure or part that will change shape, eg bend, when allowed to support its own weight for a relatively short period of time, such as 1 second.

Rigid Structure or Component: A structure or component that does not substantially change shape when subjected to the loads normally encountered in use. An example of such use may be placing and maintaining the patient interface in sealing relationship with the entrance to the patient's airway, eg, at a pressure of about 20 to 30 cmH2O.

As an example, an I-beam may include a different bending stiffness (resist bending loads) in a first direction as compared to a second orthogonal direction. In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

5.5.2 Anatomy

5.5.2.1 Anatomy of the face

Ala: The outer outer wall or "wing" of each nostril (plural: alar).

Alar Tip: The outermost point on the alar of the nose.

Alar flexion (or alar crest) point: the most posterior point in the curved base line of each alar, found in the crease formed by the union of the alar and cheek.

Pinna: The entire outer visible part of the ear.

(Nose) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nose of the frontal bone.

(Nose) cartilage framework: The nasal cartilage framework includes the septal, lateral, major and minor cartilages.

Columella: The strip of skin that separates the nostrils and extends from the nasal prominence to the upper lip.

Columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (while the two lines intersect at the lower point of the septum).

Frankfort level: line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the recess above the tragus of the pinna.

The glabella is located on the soft tissue, the most prominent point in the sagittal plane midpoint of the nasal prominence.

The lateral nasal cartilage is a substantially triangular cartilage plate. Its superior border attaches to the nasal bones and the frontal process of the maxilla, and its inferior border attaches to the greater alar cartilage.

Lip, lower (midpoint of lower lip): A point on the face between the mouth and the supramental point, in the midsagittal plane.

Lip, upper (midpoint of upper lip): A point on the face between the mouth and nose, in the midsagittal plane.

Greater alar cartilage: the plate of cartilage that underlies the outer cartilage of the nose. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the nasal alar.

Nostril (nasal eye): The approximately oval hole forming the entrance to the nasal cavity. The singular form of nostril (nare) is naris (nose eye). The nostrils are separated by the nasal septum.

Nasolabial Fold or Nasolabial Fold: A fold or groove of skin extending from each side of the nose to the corner of the mouth, which separates the cheek from the upper lip.

Nasolabial angle: The angle between the columella and the upper lip (which also meet at the lower point of the nasal septum).

Infraauricular base point: The lowest point where the pinna attaches to the skin of the face.

Supraauricular base point: The highest point where the pinna attaches to the skin of the face.

Pronasa: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

Human: the midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip region.

Anterior Mental Point: Located on the soft tissue, at the midpoint of the most anterior part of the chin.

Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the bridge point to the pronasa point.

Sagittal Plane: The vertical plane from the front (anterior) to the posterior (posterior). The midsagittal plane is the sagittal plane that divides the subject into right and left halves.

Nasal bridge point: the most concave point on the soft tissue covering the frontonasal suture area.

Septal Cartilage (Nose): The septal cartilage forms part of the septum and separates the front of the nasal cavity.

Posterior superior panel: the point at the inferior border of the alar base where the alar base joins the skin of the upper (upper) lip.

Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

Mandibular Alveolar Seat: The point of greatest concavity in the midline of the lower lip between the midpoint of the lower lip and the anterior point of the soft tissue.

5.5.2.2 Anatomy of the skull

Frontal bone: The frontal bone includes a larger vertical portion (frontal squamus), which corresponds to the area called the forehead.

Mandible: The mandible forms the lower jaw. The chin protuberance is the bony protrusion of the lower jaw that forms the chin.

Maxilla: The maxilla forms the upper jaw and sits above the mandible and below the eye sockets. The maxillary frontal process projects upward from the side of the nose and forms part of the lateral border.

Nasal Bones: The nasal bones are two small oval bones that vary in size and form in different individuals; they sit side by side in the middle and upper part of the face and form the "bridge" of the nose by their junction.

Nasion: The junction of the frontal bone and the two nasal bones, the sunken area directly between the eyes and above the bridge of the nose.

Occipital: The occiput is located at the back and lower part of the skull. It includes an oval-shaped hole (foramen magnum) through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital scale.

Orbital: The bony cavity in the skull that houses the eyeball.

Parietal Bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

Temporal Bones: The temporal bones are at the bottom and sides of the skull and support parts of the face called the temples.

Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

5.5.2.3 Anatomy of the respiratory system

Diaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thorax, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the chest cavity increases and air is drawn into the lungs.

Larynx: The larynx or larynx houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

Lung: The human respiratory organ. The conduction zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

Nasal chambers: The nasal chambers (or nasal fossa) are the large air-filled spaces above and behind the nose in the middle of the face. The nasal cavity is divided into two by a vertical wing called the septum. On the sides of the nasal cavity are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nares.

Pharynx: The part of the throat located just below (below) the nasal chambers and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (upper pharynx) (nose portion of the pharynx), oropharynx (middle pharynx) (mouth portion of the pharynx), and hypopharynx (lower pharynx).

5.5.3 User interface

Frame: Frame shall be taken to mean the mask structure carrying the tension load between two or more points of attachment to the headgear. The mask frame may be a non-airtight load carrying structure in the mask. However, some forms of mask frames may also be airtight.

Headgear: A headgear shall be taken to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a collection of one or more support bars, straps, and reinforcements configured to position and hold the user interface on the user's face (eg, for the delivery of respiratory therapy). Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

Membrane: Membrane shall be taken to mean a typically thin element, which preferably has substantially no resistance to bending, but is resistant to stretching.

Plenum: A mask plenum shall be taken to mean that portion of the patient interface having walls at least partially enclosing a volume having, in use, air pressurized therein to superatmospheric pressure. The housing may form part of a wall of the mask inflation chamber.

Seal: Can refer to the noun form of the structure (seal) or the verb form of the effect (seal). Two elements may be constructed and/or arranged to 'seal' or achieve a 'seal' between them without requiring a separate 'seal' element itself.

Shell: A shell will be taken to mean a curved and relatively thin structure having bendable, stretchable and compressible stiffness. For example, the curved structural wall of the mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

Stiffener: A stiffener shall be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

Braces: A brace will be considered a structural component designed to increase the compression resistance of another component in at least one direction.

Lace (noun): A structure used to resist tension.

Vent: (noun): A structure that permits the flow of air from the mask interior or ducts to ambient air, eg, for effective flushing of exhaled gases. For example, clinically effective irrigation may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on mask design and treatment pressure.

5.5.4 The shape of the structure

Products according to the present technology may include one or more three-dimensional mechanical structures, such as mask cushions or pushers. Three-dimensional structures can be bound by two-dimensional surfaces. These surfaces may be differentiated using markers to describe relative surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (eg, exterior) surface and a separate non-face-contacting (eg, underside or interior) surface. In another example, a structure can include a first surface and a second surface.

5.5.4.1 One-dimensional curvature

The curvature of a plane curve at P can be described as having a sign (eg, positive, negative) and magnitude (eg, the reciprocal of the radius of the circle that only touches the curve at P).

Positive curvature: If the curve turns towards the outward normal, the curvature at the point will be taken as positive (if the imaginary puppet leaves the point they have to go uphill). Such curves are often called concave.

Zero curvature: If the curve is a straight line, the curvature will be taken as zero (if the imaginary little people leave the point p, they can walk horizontally without going up or down).

Negative curvature: If the curve turns away from the outward normal, the curvature in that direction will take negative at that point (if the imaginary puppet leaves this point, they have to go downhill). Such curves are often called convex.

5.5.4.2 Two-dimensional curvature

A description of a shape at a given point on a two-dimensional surface according to the present technique may include multiple normal sections. Multiple sections may cut the surface in a plane that includes the outward normal ("normal plane"), and each section may be taken in a different direction. Each cross-section produces a planar curve with a corresponding curvature. Different curvatures at this point can have the same sign or different signs. Each curvature at that point has an amount, such as a relatively small amount.

Principal Curvature and Principal Direction: The direction of the normal plane where the curvature of the curve takes its maximum and minimum values is called the principal direction.

Area of a surface: A connected set of points on a surface. The set of points in a region may have similar characteristics, such as curvature or sign.

Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other is negative (depending on which direction the imaginary individual is turning, they can walk up or down).

Domed region: a region where the principal curvatures have the same sign at each point, eg two positive ("concave dome") or two negative ("convex dome").

Cylindrical region: a region in which one principal curvature is zero (or is zero, eg within manufacturing tolerances) and the other principal curvature is non-zero.

Planar region: A surface region in which both principal curvatures are zero (or zero, eg within manufacturing tolerances).

Surface Edge: The boundary or limit of a surface or area.

Path: In some forms of the present technology, 'path' will be taken to mean a path in the mathematical-topological sense, eg a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or journey comprising, for example, a set of points on a surface. (A hypothetical person's path is where they walk on the surface, and is similar to a garden path).

Path length: In some forms of the present technique, the 'path length' will be considered to be the distance along the surface from f(0) to f(1), ie the distance along the path on the surface. There may be more than one path between two points on the surface, and such paths may have different path lengths. (A hypothetical person's path length would be the distance they would have to walk along the path on the surface.

Straight-line distance: A straight-line distance is the distance between two points on a surface, but the surface is not considered. On a planar region, there will be paths on the surface with the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path with the same path length as the straight-line distance between two points. (For the imaginary, straight-line distances would correspond to distances "in a straight line")

5.6 Other Remarks

Portions of the disclosure of this patent document contain material that is protected by copyright. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent Office files or records, but otherwise reserves any and all copyright rights.

Unless the context clearly dictates and a range of values is provided, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, and any other value within said range Recited values or intermediate values are broadly encompassed within the present technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges and are also within the scope of the technology, subject to any expressly excluded limit in the stated range. Where the range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

Furthermore, where a value or values described herein are implemented as part of the present technology, it should be understood that such values may be approximate unless otherwise stated, and that such values may be practically Any suitable significant digit may be used to the extent technical implementations allow or require it.

Furthermore, "about", "substantially", "approximately" or any similar term as used herein means +/- 5 to +/- 10% of the stated value.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present techniques, a limited number of exemplary methods and materials are described herein.

When a particular material is identified for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus manufactured together or separately.

It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents thereof unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated by reference in their entirety to disclose and describe the methods and/or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present art is not entitled to priority to these publications as a result of prior art. In addition, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

The terms "comprises" and "comprising" are to be understood as referring to each element, each part or each step in a non-exclusive manner, indicating that the marked element, part or step may be present or utilized, Or a combination with other elements, parts or steps without a label.

The use of subject headings in the detailed description is for the convenience of the reader's reference only and should not be used to limit the subject matter that may be found throughout the disclosure or claims. Subject headings should not be used to interpret the scope of the claims or claim limitations.

Although the technology has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details not necessary to practice the technique. For example, although the terms "first" and "second" may be used, unless stated otherwise, they are not intended to denote any order, but may be used to distinguish between different elements. Additionally, although process steps in a method may be described or illustrated in order, such order is not required. Those skilled in the art will recognize that such order may be modified and/or aspects thereof may be performed concurrently or even simultaneously.

It is therefore to be understood that numerous modifications may be made to the exemplary embodiments described, and that other arrangements may be devised without departing from the spirit and scope of the technology.

Claims (99)

1. A mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

A body forming a three-dimensional shaped chamber configured for operation at the operating pressure throughout a breathing cycle of a user and configured for receiving a mouth and nostrils of the user, wherein an inner surface of the body is spaced apart from the user in use throughout the breathing cycle of the user; and

a nasal seal having an uppermost portion configured and dimensioned to avoid contact with the user's nasal ridge and contact the user's nose around at least a portion of the user's nostrils below the user's nasal ridge and along the sagittal plane of the user's nose on an underside of the user's nose, the nasal seal constructed of an at least partially impermeable material and configured to restrict airflow toward the user's eyes in use; and

a positioning and stabilising structure providing a force to hold the nasal seal in place on the user's head, a portion of the positioning and stabilising structure being configured for direct contact with the user's face between the user's lip and chin protuberance in use;

wherein at least a portion of the body is configured to allow air to enter and leave the three-dimensional forming chamber.

2. The mask of claim 1, wherein at least a portion of the body is permeable such that air can enter and exit the three-dimensionally shaped chamber through a surface of the body.

3. A mask according to any one of claims 1-2, wherein the nasal seal comprises a cantilever structure extending from the main body towards the face of the user in use, the cantilever structure being configured to form a seal around the front and sides of the perimeter of the wing base of the user's nose.

4. A mask according to claim 3, wherein the cantilever structure comprises:

a central portion configured to contact a lower region of the user's nose along a sagittal plane of the user entirely below a nasal projection of the user;

a pair of lateral ends configured to contact the user near the nasolabial folds; and

a pair of intermediate portions, each intermediate portion of the pair of intermediate portions being located between the central portion and one of the pair of lateral end portions, each intermediate portion being configured to contact a face of the user proximate the wing base.

5. The mask of claim 4, wherein a central portion of the cantilever structure forms a seal directly below the subnasal septum and nostril of the user without resting on the user's lips.

6. A patient interface according to any one of claims 4-5, wherein the intermediate portion of the cantilever structure forms a maximum width of the cantilever structure.

7. The mask according to any one of claims 4-6, wherein the nasal seal comprises a front edge and a rear edge configured to contact the user's face, wherein each intermediate portion comprises a maximum width between the front edge and the rear edge, and wherein a lateral edge at each lateral end of the nasal seal comprises a minimum width between the front edge and the rear edge, the lateral edges being connected to the mouth seal.

8. The mask of claim 7, further comprising a bridge connected to the nasal seal, and wherein the bridge extends between the maximum widths of each intermediate portion.

9. The mask according to any one of claims 1-8, wherein the body is formed from a spacer shell, foam, and/or a thermo-forming material.

10. A mask according to any one of claims 1-9, wherein a central upper portion of the perimeter of the body is provided with a plastically deformable element configured to bend and change the shape of the body.

11. The mask of claim 10, wherein the plastically deformable element is at least partially enclosed in a sleeve.

12. A patient interface according to claim 11, wherein the sleeve is made of a fabric material.

13. The mask according to any one of claims 1-12, further comprising at least one filter element configured to filter air before the air enters and/or exits the three-dimensional shaping chamber, and wherein the at least one filter element is disposed to an inner surface of the three-dimensional shaping chamber.

14. The mask of claim 13, wherein

The at least one filter element covers substantially the entire inner surface of the body, the inner surface of the three-dimensional shaped chamber including at least one fastener;

the filter element is configured to be removably connected to the at least one fastener; and

the at least one fastener is formed from a hook and loop material.

15. The mask of claim 14, wherein the at least one fastener is a plurality of fasteners arranged in a generally X-shaped configuration, each fastener of the plurality of fasteners extending generally between a periphery and a center of the body.

16. A mask according to any one of claims 13-15, wherein a rigid member is coupled to at least a portion of an outer perimeter of the filter element, the rigid member being resilient and configured to return to an intermediate position after a compressive force is removed.

17. A mask according to any one of claims 1-16, wherein the positioning and stabilizing structure comprises two resilient loops, each loop configured to engage one ear of the user.

18. The mask of claim 17, wherein the elastic ring is connected to the body around substantially the entire perimeter of the body.

19. A mask according to any one of claims 17-18, wherein the two elastic loops each form a complete, unbroken perimeter.

20. A mask according to any one of claims 17-19, wherein the elastic ring is thicker proximate the body and tapers away from a free end of the body.

21. A mask according to any one of claims 17-20, wherein the elastic ring is formed from a single piece of material and is connected together along unbroken lengths.

22. A mask according to any one of claims 17-21, wherein the elastic ring is constructed of an at least partially impermeable material and is configured to restrict airflow into and/or out of the three-dimensional shaped chamber between the positioning and stabilizing structure and the user's face.

23. A mask according to claim 22, wherein the elastic ring is constructed of a fabric material and is coated with an impermeable material to restrict airflow.

24. A mask according to any one of claims 22-23, wherein each elastic ring is configured to stretch to engage an ear of the user and provide tension configured to pull the body toward the user's face, wherein the elastic rings are configured to at least partially surround the user's mouth in a sealing arrangement and contact the user between chin and under lips.

25. A mask according to claim 24, wherein the two elastic rings and the nasal seal form a single continuous seal.

26. The mask according to any one of claims 1-25, wherein the nasal seal is configured not to extend into the nostril of the user.

27. A mask according to any one of claims 1-26, wherein the nasal seal is constructed from a single piece of material.

28. A mask according to any one of claims 1-29, wherein the nasal seal is symmetrical about a central portion configured to contact the user's nose in use along a sagittal plane that is entirely below a nasal projection.

29. The mask according to any one of claims 1-28, wherein a strap is connected to an outer perimeter of the body on a front surface of the body outside the three-dimensional shaping chamber, wherein the strap is configured to increase rigidity of the body.

30. A mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaped chamber configured for operation at the operating pressure throughout a breathing cycle of a user and configured for receiving a mouth and nostrils of the user, wherein an inner surface of the body is spaced apart from the user in use throughout the breathing cycle of the user; and

a seal-forming structure configured to form a seal against a face of the user in use, the seal-forming structure comprising:

a nasal seal configured to extend around at least a portion of the user's nostrils on an underside of the user's nose below the user's nasal ridge, an

A mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being connected to the nose seal to form a single, continuous seal,

Wherein an end of the nose seal is directly connected to an end of the mouth seal; and

positioning and stabilizing structure to provide a force to hold the seal-forming structure in place on the user's head

Wherein at least a portion of the body is configured to allow air to enter and leave the three-dimensional forming chamber.

31. A mask according to claim 30, wherein the body includes a port through which air can enter and exit the three-dimensional shaped chamber, and wherein the body is substantially impermeable and in use air can only enter and exit the three-dimensional shaped chamber through the port.

32. A mask according to claim 30, wherein at least a portion of the body is permeable such that air can enter and exit the chamber through a surface of the body.

33. A mask according to any one of claims 30-32, wherein the nasal seal comprises a cantilever structure extending from the body towards the face of the user in use, the cantilever structure being configured to form a seal around the front and sides of the perimeter of the wing base of the user's nose.

34. A mask according to claim 33, wherein the cantilever structure includes an at least partially linear front edge, and wherein the positioning and stabilizing structure is connected to the body in an orientation parallel to the front edge.

35. A mask according to any one of claims 33-34, wherein the cantilever structure comprises:

a central portion configured to contact a lower region of the nose of the user adjacent to a nasal projection of the user;

a pair of lateral ends configured to contact the user near the nasolabial folds; and

a pair of intermediate portions, each intermediate portion of the pair of intermediate portions being located between the central portion and one of the pair of lateral end portions, each intermediate portion being configured to contact a face of the user proximate the wing base.

36. The mask of claim 35, wherein a central portion of the cantilever structure forms a seal directly below the subnasal septum and nostrils of the user without resting on the user's lips.

37. A patient interface according to any one of claims 35-36, wherein the intermediate portion of the cantilever structure forms a maximum width of the cantilever structure.

38. A mask according to any one of claims 35-37, wherein the nasal seal comprises a front edge and a rear edge configured to contact the user's face, wherein each intermediate portion comprises a maximum width between the front edge and the rear edge, and wherein a lateral edge at each lateral end of the nasal seal comprises a minimum width between the front edge and the rear edge, the lateral edges being connected to the mouth seal.

39. A mask according to claim 38, further comprising a bridge connected to the seal-forming structure, and wherein the bridge extends between a maximum width of each intermediate portion.

40. A mask according to claim 39, wherein

The bridge is constructed of an elastomeric material and is connected to the seal-forming structure under tension prior to use;

the bridge is connected to an upper surface of the nasal seal, the upper surface configured to contact the user in use; and

the bridge does not contact the nasal seal between the maximum widths of each intermediate portion.

41. A mask according to any one of claims 30-40, wherein the body is formed from a spacer shell, foam, and/or a thermo-formable material.

42. A mask according to any one of claims 30-41, wherein the body is formed of a rigid or semi-rigid material, and wherein the body retains its three-dimensional shape so as to isolate an inner surface of the body from the lips of the user in use.

43. A mask according to any one of claims 30-42, wherein the body is formed from a flat sheet and includes at least one pleat.

44. A mask according to any one of claims 30-43, wherein a central upper portion of a perimeter of the body is provided with a plastically deformable element configured to bend and change a shape of the body.

45. A mask according to any one of claims 30-44, further comprising at least one filter element configured to filter air before the air enters and/or exits the three-dimensional shaped chamber, and wherein the at least one filter element is disposed to an inner surface of the chamber.

46. A mask according to claim 45, wherein

The at least one filter element covering substantially the entire inner surface of the body, the inner surface of the chamber including at least one fastener;

the filter element is configured to be removably connected to the at least one fastener; and

the at least one fastener is formed from a hook and loop material.

47. A mask according to any one of claims 45-46, wherein a rigid member is coupled to at least a portion of an outer perimeter of the filter element, the rigid member being resilient and configured to return to an intermediate position after a compressive force is removed.

48. A mask according to any one of claims 45-47, wherein an inner surface of the body includes a recess, and wherein the filter element is removably positionable within the recess.

49. A mask according to any one of claims 30-48, wherein the positioning and stabilizing structure comprises two resilient loops, each loop configured to engage one ear of the user.

50. A mask according to claim 49, wherein the elastic ring is connected to the body around at least a majority of a perimeter of the body.

51. A mask according to any one of claims 49-50, wherein the elastic ring is connected to the body around substantially the entire perimeter of the body.

52. A mask according to any one of claims 49-51, wherein the two elastic loops each form a complete, unbroken perimeter.

53. A mask according to any one of claims 49-52, wherein the elastic ring is thicker proximate the body and tapers away from a free end of the body.

54. A mask according to any one of claims 30-53, wherein the nasal seal is configured not to extend into the nostril of the user.

55. A mask according to any one of claims 30-54, wherein the nasal seal is constructed from a single piece of material.

56. A mask according to any one of claims 30-55, wherein the nasal seal is symmetrical about a central portion configured to contact the nose of the user proximate a nasal projection in use.

57. A mask according to any one of claims 30-56, wherein the body includes an outer surface and an edge between the outer surface and the inner surface, the positioning and stabilizing structure being connected to the edge.

58. A mask according to claim 57, wherein the positioning and stabilizing structure is attached to the rim by an adhesive.

59. A mask according to any one of claims 57-58, wherein the positioning and stabilizing structure includes an upper arm and a lower arm each connected to the rim, and wherein the upper arm and the lower arm are oriented substantially tangentially from a central portion of the nasal seal configured to contact a lower region of the user's nose adjacent the user's nasal projection.

60. A mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

A body forming a three-dimensional shaped chamber configured for operation at the operating pressure throughout a breathing cycle of a user and configured for receiving a mouth and nostrils of the user, wherein an inner surface of the body is spaced apart from the user in use throughout the breathing cycle of the user; and

a seal-forming structure configured to form a seal against a face of the user in use, the seal-forming structure comprising:

a nasal seal configured to extend around at least a portion of the user's nostrils on an underside of the user's nose below the user's nasal ridge, an

A mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being connected to the nose seal to form a single, continuous seal,

wherein an end of the nose seal is directly connected to an end of the mouth seal; and

positioning and stabilizing structure to provide a force to hold the seal-forming structure in place on the user's head;

wherein at least a portion of the body is configured to allow air to enter and leave the three-dimensionally shaped cavity;

Wherein the body comprises a port through which air can enter and leave the three-dimensional forming chamber, and wherein the body is substantially impermeable and in use air can only enter and leave the three-dimensional forming chamber through the port; and

wherein the nasal seal comprises a cantilever structure extending in use from the body towards the face of the user, the cantilever structure being configured to form a seal around the front and sides of the perimeter of the wing base of the user's nose.

61. A face mask according to claim 60, wherein the body is comprised of at least one of cellulose acetate, nitrocellulose, polyamide, polycarbonate, polypropylene, and polytetrafluoroethylene.

62. A mask according to claim 60, wherein the body is at least partially constructed of a webbing material, and wherein the webbing material is at least partially coated with an impermeable layer.

63. A face mask according to claim 62, wherein the impermeable layer comprises at least one of rubber, polyvinyl chloride (PVC), polyurethane (PU), silicone elastomer, fluoropolymer, and wax.

64. A mask according to any one of claims 62-63, wherein the impermeable layer is applied to an inner surface and/or an outer surface of the body, the outer surface being opposite the inner surface.

65. A face mask according to any one of claims 60-64, wherein the port includes at least one micro-aperture through which air can enter and exit the three-dimensional shaping chamber.

66. A mask according to any one of claims 60-64, wherein the port includes at least one visible aperture through which air can enter and exit the three-dimensional shaped chamber.

67. A mask according to any one of claims 60-64, wherein the body is constructed of at least a first material that is substantially impermeable and a second material that is more permeable than the first material, wherein the second material forms the port.

68. A mask according to any one of claims 60-67, wherein the port is located near a lower region of the body that is adjacent the mouth seal.

69. A mask according to any one of claims 60-68, wherein the port is located along a central axis of the body extending between the nasal seal and the mouth seal, the central axis configured to be located parallel to a sagittal plane of the user in use.

70. A mask according to any one of claims 60-68, wherein the port is located near a side of the body that is near an end of the nasal seal and an end of the mouth seal.

71. A mask according to any one of claims 60-70, wherein the port is a first port and the body further comprises a second port spaced apart from the first port.

72. A mask according to claim 71, wherein the second port is a one-way valve configured to allow air into the three-dimensional shaped chamber and configured to block air from exiting the three-dimensional shaped chamber.

73. A mask according to any one of claims 60-72, wherein the mask is provided with at least one replaceable filter element.

74. A mask according to claim 73, wherein the filter element is disposed on an inner surface of the body.

75. A mask according to claim 74, wherein the filter element covers substantially the entire inner surface of the body.

76. A mask according to claim 73, wherein the filter element is disposed within the port.

77. A mask according to any one of claims 60-76, wherein the body is formed of a rigid or semi-rigid material, and wherein the body retains its three-dimensional shape so as to isolate an inner surface of the body from the lips of the user in use.

78. A mask according to any one of claims 60-77, wherein the nasal seal comprises a cantilever structure extending from the body towards the face of the user in use, the cantilever structure configured to form a seal around a front and sides of a perimeter of a wing base of the user's nose.

79. A mask according to claim 78, wherein the cantilever structure comprises:

a central portion configured to contact a lower region of the user's nose along a sagittal plane of the user entirely below a nasal projection of the user;

a pair of lateral ends configured to contact the user near the nasolabial folds; and

a pair of intermediate portions, each intermediate portion of the pair of intermediate portions being located between the central portion and one of the pair of lateral end portions, each intermediate portion being configured to contact a face of the user proximate the wing base.

80. A mask according to claim 79, wherein a central portion of the cantilever structure forms a seal directly below the subnasal septum and nostrils of the user without resting on the user's lips.

81. A mask according to claims 60-80, wherein the positioning and stabilizing structure comprises two resilient loops, each loop configured to engage one ear of the user.

82. A mask according to any one of claims 60-81, wherein the positioning and stabilizing structure includes an upper arm and a lower arm that are each connected to the body, and wherein the upper arm and the lower arm are oriented substantially tangentially from a central portion of the nasal seal configured to contact a lower region of the user's nose along the sagittal plane entirely below a point near the user's nasal prominence.

83. A mask for use at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

a body forming a three-dimensional shaped chamber configured for operation at the operating pressure throughout a breathing cycle of a user and configured for receiving a mouth and nostrils of the user, wherein an inner surface of the body is spaced apart from the user in use throughout the breathing cycle of the user; and

A seal-forming structure configured to form a seal against a face of the user in use, the seal-forming structure comprising:

a nasal seal configured to extend around at least a portion of the user's nostrils on an underside of the user's nose below the user's nasal ridge, an

A mouth seal configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, the mouth seal being connected to the nose seal to form a single, continuous seal,

wherein an end of the nose seal is directly connected to an end of the mouth seal; and

positioning and stabilizing structure to provide a force to hold the seal-forming structure in place on the user's head; and

at least one filter element configured for filtering air prior to entering and/or exiting the three-dimensional forming chamber, and wherein the at least one filter element is provided to an inner surface of the body;

wherein at least a portion of the body is configured to allow air to enter and leave the three-dimensional forming chamber;

wherein at least a portion of the body is permeable such that air can enter and exit the chamber through a surface of the body; and

Wherein a rigid member is coupled to at least a portion of the outer perimeter of the filter element, the rigid member being resilient and configured to return to an intermediate position after the compressive force is removed.

84. A mask according to claim 83, wherein the at least a portion of the body is configured to allow air to enter and exit the three-dimensional shaped chamber includes a first permeability, and wherein the filter element includes a second permeability that is less than the first permeability.

85. A mask according to any one of claims 83-84, wherein the filter includes an electrical charge.

86. A mask according to any one of claims 83-85, wherein:

the inner surface of the body may include at least one fastener;

the filter element is configured to be removably connected to the at least one fastener; and

the at least one fastener is formed from a hook and loop material.

87. A face mask according to claim 86, wherein the filter element is substantially flush with the inner surface when connected to the at least one fastener.

88. A mask according to any one of claims 83-87, wherein an inner surface of the body includes a recess, and wherein the filter element is removably positionable within the recess.

89. A mask according to any one of claims 83-88, wherein the filter element covers substantially the entire inner surface of the body.

90. A mask according to any one of claims 83-89, wherein the filter element is constructed of a rigid or semi-rigid material and is configured to act as a rigid member that maintains the three-dimensional shape of the chamber.

91. A mask according to any one of claims 83-90, wherein the nasal seal comprises a cantilever structure extending from the body towards the face of the user in use, the cantilever structure being configured to form a seal around the front and sides of the perimeter of the wing base of the user's nose.

92. A mask according to claim 91, wherein the rigid member of the filter element is selectively deformable so as to fit around the cantilever structure.

93. A mask according to any one of claims 91-92, wherein the cantilever structure comprises:

a central portion configured to contact a lower region of the user's nose along a sagittal plane of the user entirely below a nasal projection of the user;

a pair of lateral ends configured to contact the user near the nasolabial folds; and

A pair of intermediate portions, each intermediate portion of the pair of intermediate portions being located between the central portion and one of the pair of lateral end portions, each intermediate portion being configured to contact a face of the user proximate the wing base.

94. A mask according to any one of claims 83-93, wherein a central upper portion of a perimeter of the body is provided with a plastically deformable element configured to bend and change a shape of the body.

95. A mask according to claim 94, wherein the rigid member is more resilient than the plastically deformable member.

96. A mask according to any one of claims 83-95, wherein the positioning and stabilizing structure comprises two resilient loops, each loop configured to engage one ear of the user.

97. A mask according to claim 96, wherein the elastic ring is connected to the body around at least a majority of a perimeter of the body.

98. A mask according to any one of claims 96-97, wherein the two elastic loops each form a complete, unbroken perimeter.

99. A mask according to any one of claims 83-98, wherein the nasal seal is symmetrical about a central portion configured to contact the user's nose in use along a sagittal plane that is entirely below a nasal projection.

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